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FDA 510(k) Premarket Notification - AIR Recon DL

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Summary

The FDA has published a 510(k) premarket notification for the AIR Recon DL, a device from GE Medical Systems. This notification indicates the device has undergone a review process to demonstrate substantial equivalence to legally marketed predicate devices.

Published by FDA on accessdata.fda.gov . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .
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What changed

This document is a 510(k) premarket notification filing for the AIR Recon DL device, submitted by GE Medical Systems. The 510(k) process allows the FDA to determine if a medical device is substantially equivalent to a legally marketed predicate device, thereby permitting its marketing in the United States. This specific filing (K252379) pertains to a device that likely incorporates AI or machine learning capabilities, given the context of the FDA's AI-enabled medical devices feed.

For manufacturers and medical device makers, this notification signifies a cleared device available for market. While this is not a rule or guidance document, it represents a regulatory milestone for the specific product. Compliance officers should note that the FDA is actively tracking and providing information on AI-enabled medical devices, suggesting increased scrutiny and potential future regulatory developments in this area. No immediate actions are required based solely on this notification, but it serves as an indicator of regulatory activity and product clearance within the AI medical device space.

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Mar 23, 2026

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510(k) Premarket Notification

- Databases

| | | | | | 510(k) | \| | DeNovo | \| | Registration & Listing | \| | Adverse Events | \| | Recalls | \| | PMA | \| | HDE | \| | Classification | \| | Standards |

| CFR Title 21 | \| | Radiation-Emitting Products | \| | X-Ray Assembler | \| | Medsun Reports | \| | CLIA | \| | TPLC | | | 510(k) | | | DeNovo | | | Registration & Listing | | | Adverse Events | | | Recalls | | | PMA | | | HDE | | | Classification | | | Standards | CFR Title 21 | | | Radiation-Emitting Products | | | X-Ray Assembler | | | Medsun Reports | | | CLIA | | | TPLC | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 510(k) | | | DeNovo | | | Registration & Listing | | | Adverse Events | | | Recalls | | | PMA | | | HDE | | | Classification | | | Standards | | | | | | | | | | | | | | | | |
| CFR Title 21 | | | Radiation-Emitting Products | | | X-Ray Assembler | | | Medsun Reports | | | CLIA | | | TPLC | | | | | | | | | | | | | | | | | | | | | | |

| | \| New Search \| Back To Search Results \| | New Search | Back To Search Results | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| New Search | Back To Search Results | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| \| \| Device Classification Name \| System, Nuclear Magnetic Resonance Imaging \| \| \| \|
\| --- \| --- \| \| \| \|
\| 510(k) Number \| K252379 \| \| \| \|
\| Device Name \| AIR Recon DL \| \| \| \|
\| Applicant \| \\| Ge Medical Systems, LLC \\|
\\| 3200 N Grandview Blvd. \\|
\\| Waukesha, 
WI 
53188 \\| \| Ge Medical Systems, LLC \| 3200 N Grandview Blvd. \| Waukesha, 
WI 
53188 \|
\| Ge Medical Systems, LLC \| \| \| \| \|
\| 3200 N Grandview Blvd. \| \| \| \| \|
\| Waukesha, 
WI 
53188 \| \| \| \| \|
\| Applicant Contact \| Derek Schmidtke \| \| \| \|
\| Correspondent \| \\| Ge Medical Systems, LLC \\|
\\| 3200 N Grandview Blvd. \\|
\\| Waukesha, 
WI 
53188 \\| \| Ge Medical Systems, LLC \| 3200 N Grandview Blvd. \| Waukesha, 
WI 
53188 \|
\| Ge Medical Systems, LLC \| \| \| \| \|
\| 3200 N Grandview Blvd. \| \| \| \| \|
\| Waukesha, 
WI 
53188 \| \| \| \| \|
\| Correspondent Contact \| Andrew Turner \| \| \| \|
\| Regulation Number \| 892.1000 \| \| \| \|
\| Classification Product Code \| \\| LNH \\| \| LNH \| \| \|
\| LNH \| \| \| \| \|
\| Date Received \| 07/30/2025 \| \| \| \|
\| Decision Date \| 12/23/2025 \| \| \| \|
\| Decision \| Substantially Equivalent 

(SESE) \\\|  \\\|  \\\|  \\\|

\| Regulation Medical Specialty \| Radiology \| \| \| \|
\| 510k Review Panel \| Radiology \| \| \| \|
\| Summary \| Summary \| \| \| \|
\| Type \| Traditional \| \| \| \|
\| Reviewed by Third Party \| No \| \| \| \|
\| Combination Product \| No \| \| \| \|
\| Predetermined Change
Control Plan Authorized \| No \| \| \| \| \| Device Classification Name \| System, Nuclear Magnetic Resonance Imaging \| 510(k) Number \| K252379 \| Device Name \| AIR Recon DL \| Applicant \| \| Ge Medical Systems, LLC \|
\| 3200 N Grandview Blvd. \|
\| Waukesha, 
WI 
53188 \| \| Ge Medical Systems, LLC \| 3200 N Grandview Blvd. \| Waukesha, 
WI 
53188 \| Applicant Contact \| Derek Schmidtke \| Correspondent \| \| Ge Medical Systems, LLC \|
\| 3200 N Grandview Blvd. \|
\| Waukesha, 
WI 
53188 \| \| Ge Medical Systems, LLC \| 3200 N Grandview Blvd. \| Waukesha, 
WI 
53188 \| Correspondent Contact \| Andrew Turner \| Regulation Number \| 892.1000 \| Classification Product Code \| \| LNH \| \| LNH \| Date Received \| 07/30/2025 \| Decision Date \| 12/23/2025 \| Decision \| Substantially Equivalent 

(SESE) \\| Regulation Medical Specialty \\| Radiology \\| 510k Review Panel \\| Radiology \\| Summary \\| [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252379.pdf) \\| Type \\| Traditional \\| Reviewed by Third Party \\| No \\| Combination Product \\| No \\| Predetermined Change

Control Plan Authorized \| No \|
\| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \|
\| Device Classification Name \| System, Nuclear Magnetic Resonance Imaging \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| 510(k) Number \| K252379 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Device Name \| AIR Recon DL \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Applicant \| \| Ge Medical Systems, LLC \|
\| 3200 N Grandview Blvd. \|
\| Waukesha, 
WI 
53188 \| \| Ge Medical Systems, LLC \| 3200 N Grandview Blvd. \| Waukesha, 
WI 
53188 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Ge Medical Systems, LLC \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| 3200 N Grandview Blvd. \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Waukesha, 
WI 
53188 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Applicant Contact \| Derek Schmidtke \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Correspondent \| \| Ge Medical Systems, LLC \|
\| 3200 N Grandview Blvd. \|
\| Waukesha, 
WI 
53188 \| \| Ge Medical Systems, LLC \| 3200 N Grandview Blvd. \| Waukesha, 
WI 
53188 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Ge Medical Systems, LLC \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| 3200 N Grandview Blvd. \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Waukesha, 
WI 
53188 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Correspondent Contact \| Andrew Turner \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Regulation Number \| 892.1000 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Classification Product Code \| \| LNH \| \| LNH \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| LNH \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Date Received \| 07/30/2025 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Decision Date \| 12/23/2025 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Decision \| Substantially Equivalent 

(SESE) \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|

\| Regulation Medical Specialty \| Radiology \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| 510k Review Panel \| Radiology \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Summary \| Summary \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Type \| Traditional \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Reviewed by Third Party \| No \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Combination Product \| No \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Predetermined Change
Control Plan Authorized \| No \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| | \| Device Classification Name \| System, Nuclear Magnetic Resonance Imaging \| \| \| \|
\| --- \| --- \| \| \| \|
\| 510(k) Number \| K252379 \| \| \| \|
\| Device Name \| AIR Recon DL \| \| \| \|
\| Applicant \| \| Ge Medical Systems, LLC \|
\| 3200 N Grandview Blvd. \|
\| Waukesha, 
WI 
53188 \| \| Ge Medical Systems, LLC \| 3200 N Grandview Blvd. \| Waukesha, 
WI 
53188 \|
\| Ge Medical Systems, LLC \| \| \| \| \|
\| 3200 N Grandview Blvd. \| \| \| \| \|
\| Waukesha, 
WI 
53188 \| \| \| \| \|
\| Applicant Contact \| Derek Schmidtke \| \| \| \|
\| Correspondent \| \| Ge Medical Systems, LLC \|
\| 3200 N Grandview Blvd. \|
\| Waukesha, 
WI 
53188 \| \| Ge Medical Systems, LLC \| 3200 N Grandview Blvd. \| Waukesha, 
WI 
53188 \|
\| Ge Medical Systems, LLC \| \| \| \| \|
\| 3200 N Grandview Blvd. \| \| \| \| \|
\| Waukesha, 
WI 
53188 \| \| \| \| \|
\| Correspondent Contact \| Andrew Turner \| \| \| \|
\| Regulation Number \| 892.1000 \| \| \| \|
\| Classification Product Code \| \| LNH \| \| LNH \| \| \|
\| LNH \| \| \| \| \|
\| Date Received \| 07/30/2025 \| \| \| \|
\| Decision Date \| 12/23/2025 \| \| \| \|
\| Decision \| Substantially Equivalent 

(SESE) \\|  \\|  \\|  \\|

\| Regulation Medical Specialty \| Radiology \| \| \| \|
\| 510k Review Panel \| Radiology \| \| \| \|
\| Summary \| Summary \| \| \| \|
\| Type \| Traditional \| \| \| \|
\| Reviewed by Third Party \| No \| \| \| \|
\| Combination Product \| No \| \| \| \|
\| Predetermined Change
Control Plan Authorized \| No \| \| \| \| | Device Classification Name | System, Nuclear Magnetic Resonance Imaging | 510(k) Number | K252379 | Device Name | AIR Recon DL | Applicant | \| Ge Medical Systems, LLC \|
\| 3200 N Grandview Blvd. \|
\| Waukesha, 
WI 
53188 \| | Ge Medical Systems, LLC | 3200 N Grandview Blvd. | Waukesha, 
WI 
53188 | Applicant Contact | Derek Schmidtke | Correspondent | \| Ge Medical Systems, LLC \|
\| 3200 N Grandview Blvd. \|
\| Waukesha, 
WI 
53188 \| | Ge Medical Systems, LLC | 3200 N Grandview Blvd. | Waukesha, 
WI 
53188 | Correspondent Contact | Andrew Turner | Regulation Number | 892.1000 | Classification Product Code | \| LNH \| | LNH | Date Received | 07/30/2025 | Decision Date | 12/23/2025 | Decision | Substantially Equivalent 

(SESE) \| Regulation Medical Specialty \| Radiology \| 510k Review Panel \| Radiology \| Summary \| [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252379.pdf) \| Type \| Traditional \| Reviewed by Third Party \| No \| Combination Product \| No \| Predetermined Change

Control Plan Authorized | No |
| \| Device Classification Name \| System, Nuclear Magnetic Resonance Imaging \| \| \| \|
\| --- \| --- \| \| \| \|
\| 510(k) Number \| K252379 \| \| \| \|
\| Device Name \| AIR Recon DL \| \| \| \|
\| Applicant \| \| Ge Medical Systems, LLC \|
\| 3200 N Grandview Blvd. \|
\| Waukesha, 
WI 
53188 \| \| Ge Medical Systems, LLC \| 3200 N Grandview Blvd. \| Waukesha, 
WI 
53188 \|
\| Ge Medical Systems, LLC \| \| \| \| \|
\| 3200 N Grandview Blvd. \| \| \| \| \|
\| Waukesha, 
WI 
53188 \| \| \| \| \|
\| Applicant Contact \| Derek Schmidtke \| \| \| \|
\| Correspondent \| \| Ge Medical Systems, LLC \|
\| 3200 N Grandview Blvd. \|
\| Waukesha, 
WI 
53188 \| \| Ge Medical Systems, LLC \| 3200 N Grandview Blvd. \| Waukesha, 
WI 
53188 \|
\| Ge Medical Systems, LLC \| \| \| \| \|
\| 3200 N Grandview Blvd. \| \| \| \| \|
\| Waukesha, 
WI 
53188 \| \| \| \| \|
\| Correspondent Contact \| Andrew Turner \| \| \| \|
\| Regulation Number \| 892.1000 \| \| \| \|
\| Classification Product Code \| \| LNH \| \| LNH \| \| \|
\| LNH \| \| \| \| \|
\| Date Received \| 07/30/2025 \| \| \| \|
\| Decision Date \| 12/23/2025 \| \| \| \|
\| Decision \| Substantially Equivalent 

(SESE) \\|  \\|  \\|  \\|

\| Regulation Medical Specialty \| Radiology \| \| \| \|
\| 510k Review Panel \| Radiology \| \| \| \|
\| Summary \| Summary \| \| \| \|
\| Type \| Traditional \| \| \| \|
\| Reviewed by Third Party \| No \| \| \| \|
\| Combination Product \| No \| \| \| \|
\| Predetermined Change
Control Plan Authorized \| No \| \| \| \| | Device Classification Name | System, Nuclear Magnetic Resonance Imaging | 510(k) Number | K252379 | Device Name | AIR Recon DL | Applicant | \| Ge Medical Systems, LLC \|
\| 3200 N Grandview Blvd. \|
\| Waukesha, 
WI 
53188 \| | Ge Medical Systems, LLC | 3200 N Grandview Blvd. | Waukesha, 
WI 
53188 | Applicant Contact | Derek Schmidtke | Correspondent | \| Ge Medical Systems, LLC \|
\| 3200 N Grandview Blvd. \|
\| Waukesha, 
WI 
53188 \| | Ge Medical Systems, LLC | 3200 N Grandview Blvd. | Waukesha, 
WI 
53188 | Correspondent Contact | Andrew Turner | Regulation Number | 892.1000 | Classification Product Code | \| LNH \| | LNH | Date Received | 07/30/2025 | Decision Date | 12/23/2025 | Decision | Substantially Equivalent 

(SESE) \| Regulation Medical Specialty \| Radiology \| 510k Review Panel \| Radiology \| Summary \| [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252379.pdf) \| Type \| Traditional \| Reviewed by Third Party \| No \| Combination Product \| No \| Predetermined Change

Control Plan Authorized | No | |
| Device Classification Name | System, Nuclear Magnetic Resonance Imaging | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 510(k) Number | K252379 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Device Name | AIR Recon DL | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant | \| Ge Medical Systems, LLC \|
\| 3200 N Grandview Blvd. \|
\| Waukesha, 
WI 
53188 \| | Ge Medical Systems, LLC | 3200 N Grandview Blvd. | Waukesha, 
WI 
53188 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Ge Medical Systems, LLC | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 3200 N Grandview Blvd. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Waukesha, 
WI 
53188 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant Contact | Derek Schmidtke | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent | \| Ge Medical Systems, LLC \|
\| 3200 N Grandview Blvd. \|
\| Waukesha, 
WI 
53188 \| | Ge Medical Systems, LLC | 3200 N Grandview Blvd. | Waukesha, 
WI 
53188 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Ge Medical Systems, LLC | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 3200 N Grandview Blvd. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Waukesha, 
WI 
53188 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent Contact | Andrew Turner | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Regulation Number | 892.1000 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Classification Product Code | \| LNH \| | LNH | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| LNH | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Date Received | 07/30/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Decision Date | 12/23/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Decision | Substantially Equivalent 

(SESE) \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|

| Regulation Medical Specialty | Radiology | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 510k Review Panel | Radiology | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Summary | Summary | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Type | Traditional | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Reviewed by Third Party | No | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Combination Product | No | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Predetermined Change
Control Plan Authorized | No | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | New Search | Back To Search Results | | New Search | Back To Search Results | | \| Device Classification Name \| System, Nuclear Magnetic Resonance Imaging \| \| \| \|
\| --- \| --- \| \| \| \|
\| 510(k) Number \| K252379 \| \| \| \|
\| Device Name \| AIR Recon DL \| \| \| \|
\| Applicant \| \| Ge Medical Systems, LLC \|
\| 3200 N Grandview Blvd. \|
\| Waukesha, 
WI 
53188 \| \| Ge Medical Systems, LLC \| 3200 N Grandview Blvd. \| Waukesha, 
WI 
53188 \|
\| Ge Medical Systems, LLC \| \| \| \| \|
\| 3200 N Grandview Blvd. \| \| \| \| \|
\| Waukesha, 
WI 
53188 \| \| \| \| \|
\| Applicant Contact \| Derek Schmidtke \| \| \| \|
\| Correspondent \| \| Ge Medical Systems, LLC \|
\| 3200 N Grandview Blvd. \|
\| Waukesha, 
WI 
53188 \| \| Ge Medical Systems, LLC \| 3200 N Grandview Blvd. \| Waukesha, 
WI 
53188 \|
\| Ge Medical Systems, LLC \| \| \| \| \|
\| 3200 N Grandview Blvd. \| \| \| \| \|
\| Waukesha, 
WI 
53188 \| \| \| \| \|
\| Correspondent Contact \| Andrew Turner \| \| \| \|
\| Regulation Number \| 892.1000 \| \| \| \|
\| Classification Product Code \| \| LNH \| \| LNH \| \| \|
\| LNH \| \| \| \| \|
\| Date Received \| 07/30/2025 \| \| \| \|
\| Decision Date \| 12/23/2025 \| \| \| \|
\| Decision \| Substantially Equivalent 

(SESE) \\|  \\|  \\|  \\|

\| Regulation Medical Specialty \| Radiology \| \| \| \|
\| 510k Review Panel \| Radiology \| \| \| \|
\| Summary \| Summary \| \| \| \|
\| Type \| Traditional \| \| \| \|
\| Reviewed by Third Party \| No \| \| \| \|
\| Combination Product \| No \| \| \| \|
\| Predetermined Change
Control Plan Authorized \| No \| \| \| \| | Device Classification Name | System, Nuclear Magnetic Resonance Imaging | 510(k) Number | K252379 | Device Name | AIR Recon DL | Applicant | \| Ge Medical Systems, LLC \|
\| 3200 N Grandview Blvd. \|
\| Waukesha, 
WI 
53188 \| | Ge Medical Systems, LLC | 3200 N Grandview Blvd. | Waukesha, 
WI 
53188 | Applicant Contact | Derek Schmidtke | Correspondent | \| Ge Medical Systems, LLC \|
\| 3200 N Grandview Blvd. \|
\| Waukesha, 
WI 
53188 \| | Ge Medical Systems, LLC | 3200 N Grandview Blvd. | Waukesha, 
WI 
53188 | Correspondent Contact | Andrew Turner | Regulation Number | 892.1000 | Classification Product Code | \| LNH \| | LNH | Date Received | 07/30/2025 | Decision Date | 12/23/2025 | Decision | Substantially Equivalent 

(SESE) \| Regulation Medical Specialty \| Radiology \| 510k Review Panel \| Radiology \| Summary \| [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252379.pdf) \| Type \| Traditional \| Reviewed by Third Party \| No \| Combination Product \| No \| Predetermined Change

Control Plan Authorized | No |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Device Classification Name | System, Nuclear Magnetic Resonance Imaging | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 510(k) Number | K252379 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Device Name | AIR Recon DL | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant | \| Ge Medical Systems, LLC \|
\| 3200 N Grandview Blvd. \|
\| Waukesha, 
WI 
53188 \| | Ge Medical Systems, LLC | 3200 N Grandview Blvd. | Waukesha, 
WI 
53188 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Ge Medical Systems, LLC | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 3200 N Grandview Blvd. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Waukesha, 
WI 
53188 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant Contact | Derek Schmidtke | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent | \| Ge Medical Systems, LLC \|
\| 3200 N Grandview Blvd. \|
\| Waukesha, 
WI 
53188 \| | Ge Medical Systems, LLC | 3200 N Grandview Blvd. | Waukesha, 
WI 
53188 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Ge Medical Systems, LLC | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 3200 N Grandview Blvd. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Waukesha, 
WI 
53188 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent Contact | Andrew Turner | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Regulation Number | 892.1000 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Classification Product Code | \| LNH \| | LNH | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| LNH | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Date Received | 07/30/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Decision Date | 12/23/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Decision | Substantially Equivalent 

(SESE) \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|

| Regulation Medical Specialty | Radiology | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 510k Review Panel | Radiology | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Summary | Summary | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Type | Traditional | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Reviewed by Third Party | No | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Combination Product | No | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Predetermined Change
Control Plan Authorized | No | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Device Classification Name | System, Nuclear Magnetic Resonance Imaging | | | |
| --- | --- | | | |
| 510(k) Number | K252379 | | | |
| Device Name | AIR Recon DL | | | |
| Applicant | \| Ge Medical Systems, LLC \|
\| 3200 N Grandview Blvd. \|
\| Waukesha, 
WI 
53188 \| | Ge Medical Systems, LLC | 3200 N Grandview Blvd. | Waukesha, 
WI 
53188 |
| Ge Medical Systems, LLC | | | | |
| 3200 N Grandview Blvd. | | | | |
| Waukesha, 
WI 
53188 | | | | |
| Applicant Contact | Derek Schmidtke | | | |
| Correspondent | \| Ge Medical Systems, LLC \|
\| 3200 N Grandview Blvd. \|
\| Waukesha, 
WI 
53188 \| | Ge Medical Systems, LLC | 3200 N Grandview Blvd. | Waukesha, 
WI 
53188 |
| Ge Medical Systems, LLC | | | | |
| 3200 N Grandview Blvd. | | | | |
| Waukesha, 
WI 
53188 | | | | |
| Correspondent Contact | Andrew Turner | | | |
| Regulation Number | 892.1000 | | | |
| Classification Product Code | \| LNH \| | LNH | | |
| LNH | | | | |
| Date Received | 07/30/2025 | | | |
| Decision Date | 12/23/2025 | | | |
| Decision | Substantially Equivalent 

(SESE) \|  \|  \|  \|

| Regulation Medical Specialty | Radiology | | | |
| 510k Review Panel | Radiology | | | |
| Summary | Summary | | | |
| Type | Traditional | | | |
| Reviewed by Third Party | No | | | |
| Combination Product | No | | | |
| Predetermined Change
Control Plan Authorized | No | | | | | Device Classification Name | System, Nuclear Magnetic Resonance Imaging | 510(k) Number | K252379 | Device Name | AIR Recon DL | Applicant | | Ge Medical Systems, LLC |
| 3200 N Grandview Blvd. |
| Waukesha, 
WI 
53188 | | Ge Medical Systems, LLC | 3200 N Grandview Blvd. | Waukesha, 
WI 
53188 | Applicant Contact | Derek Schmidtke | Correspondent | | Ge Medical Systems, LLC |
| 3200 N Grandview Blvd. |
| Waukesha, 
WI 
53188 | | Ge Medical Systems, LLC | 3200 N Grandview Blvd. | Waukesha, 
WI 
53188 | Correspondent Contact | Andrew Turner | Regulation Number | 892.1000 | Classification Product Code | | LNH | | LNH | Date Received | 07/30/2025 | Decision Date | 12/23/2025 | Decision | Substantially Equivalent 

(SESE) | Regulation Medical Specialty | Radiology | 510k Review Panel | Radiology | Summary | [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252379.pdf) | Type | Traditional | Reviewed by Third Party | No | Combination Product | No | Predetermined Change
Control Plan Authorized No
\ New Search \
New Search Back To Search Results
\ \
\ --- \
\ 510(k) Number \
\ Device Name \
\ Applicant \
\\ 3200 N Grandview Blvd. \\
\\ Waukesha,  
WI 
53188 \\\| \\| Ge Medical Systems, LLC \\| 3200 N Grandview Blvd. \\| Waukesha, 
WI 
53188 \\|

\| Ge Medical Systems, LLC \| \| \| \| \|
\| 3200 N Grandview Blvd. \| \| \| \| \|
\| Waukesha, 
WI 
53188 \| \| \| \| \|
\| Applicant Contact \| Derek Schmidtke \| \| \| \|
\| Correspondent \| \| Ge Medical Systems, LLC \|
\| 3200 N Grandview Blvd. \|
\| Waukesha, 
WI 
53188 \| \| Ge Medical Systems, LLC \| 3200 N Grandview Blvd. \| Waukesha, 
WI 
53188 \|
\| Ge Medical Systems, LLC \| \| \| \| \|
\| 3200 N Grandview Blvd. \| \| \| \| \|
\| Waukesha, 
WI 
53188 \| \| \| \| \|
\| Correspondent Contact \| Andrew Turner \| \| \| \|
\| Regulation Number \| 892.1000 \| \| \| \|
\| Classification Product Code \| \| LNH \| \| LNH \| \| \|
\| LNH \| \| \| \| \|
\| Date Received \| 07/30/2025 \| \| \| \|
\| Decision Date \| 12/23/2025 \| \| \| \|
\| Decision \| Substantially Equivalent 

(SESE) \\|  \\|  \\|  \\|

\| Regulation Medical Specialty \| Radiology \| \| \| \|
\| 510k Review Panel \| Radiology \| \| \| \|
\| Summary \| Summary \| \| \| \|
\| Type \| Traditional \| \| \| \|
\| Reviewed by Third Party \| No \| \| \| \|
\| Combination Product \| No \| \| \| \|
\| Predetermined Change
Control Plan Authorized \| No \| \| \| \| | Device Classification Name | System, Nuclear Magnetic Resonance Imaging | 510(k) Number | K252379 | Device Name | AIR Recon DL | Applicant | \| Ge Medical Systems, LLC \|
\| 3200 N Grandview Blvd. \|
\| Waukesha, 
WI 
53188 \| | Ge Medical Systems, LLC | 3200 N Grandview Blvd. | Waukesha, 
WI 
53188 | Applicant Contact | Derek Schmidtke | Correspondent | \| Ge Medical Systems, LLC \|
\| 3200 N Grandview Blvd. \|
\| Waukesha, 
WI 
53188 \| | Ge Medical Systems, LLC | 3200 N Grandview Blvd. | Waukesha, 
WI 
53188 | Correspondent Contact | Andrew Turner | Regulation Number | 892.1000 | Classification Product Code | \| LNH \| | LNH | Date Received | 07/30/2025 | Decision Date | 12/23/2025 | Decision | Substantially Equivalent 

(SESE) \| Regulation Medical Specialty \| Radiology \| 510k Review Panel \| Radiology \| Summary \| [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252379.pdf) \| Type \| Traditional \| Reviewed by Third Party \| No \| Combination Product \| No \| Predetermined Change

Control Plan Authorized | No |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Device Classification Name | System, Nuclear Magnetic Resonance Imaging | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 510(k) Number | K252379 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Device Name | AIR Recon DL | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant | \| Ge Medical Systems, LLC \|
\| 3200 N Grandview Blvd. \|
\| Waukesha, 
WI 
53188 \| | Ge Medical Systems, LLC | 3200 N Grandview Blvd. | Waukesha, 
WI 
53188 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Ge Medical Systems, LLC | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 3200 N Grandview Blvd. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Waukesha, 
WI 
53188 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant Contact | Derek Schmidtke | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent | \| Ge Medical Systems, LLC \|
\| 3200 N Grandview Blvd. \|
\| Waukesha, 
WI 
53188 \| | Ge Medical Systems, LLC | 3200 N Grandview Blvd. | Waukesha, 
WI 
53188 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Ge Medical Systems, LLC | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 3200 N Grandview Blvd. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Waukesha, 
WI 
53188 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent Contact | Andrew Turner | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Regulation Number | 892.1000 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Classification Product Code | \| LNH \| | LNH | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| LNH | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Date Received | 07/30/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Decision Date | 12/23/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Decision | Substantially Equivalent 

(SESE) \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|

| Regulation Medical Specialty | Radiology | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 510k Review Panel | Radiology | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Summary | Summary | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Type | Traditional | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Reviewed by Third Party | No | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Combination Product | No | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Predetermined Change
Control Plan Authorized | No | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Device Classification Name | System, Nuclear Magnetic Resonance Imaging | | | |
| --- | --- | | | |
| 510(k) Number | K252379 | | | |
| Device Name | AIR Recon DL | | | |
| Applicant | \| Ge Medical Systems, LLC \|
\| 3200 N Grandview Blvd. \|
\| Waukesha, 
WI 
53188 \| | Ge Medical Systems, LLC | 3200 N Grandview Blvd. | Waukesha, 
WI 
53188 |
| Ge Medical Systems, LLC | | | | |
| 3200 N Grandview Blvd. | | | | |
| Waukesha, 
WI 
53188 | | | | |
| Applicant Contact | Derek Schmidtke | | | |
| Correspondent | \| Ge Medical Systems, LLC \|
\| 3200 N Grandview Blvd. \|
\| Waukesha, 
WI 
53188 \| | Ge Medical Systems, LLC | 3200 N Grandview Blvd. | Waukesha, 
WI 
53188 |
| Ge Medical Systems, LLC | | | | |
| 3200 N Grandview Blvd. | | | | |
| Waukesha, 
WI 
53188 | | | | |
| Correspondent Contact | Andrew Turner | | | |
| Regulation Number | 892.1000 | | | |
| Classification Product Code | \| LNH \| | LNH | | |
| LNH | | | | |
| Date Received | 07/30/2025 | | | |
| Decision Date | 12/23/2025 | | | |
| Decision | Substantially Equivalent 

(SESE) \|  \|  \|  \|

| Regulation Medical Specialty | Radiology | | | |
| 510k Review Panel | Radiology | | | |
| Summary | Summary | | | |
| Type | Traditional | | | |
| Reviewed by Third Party | No | | | |
| Combination Product | No | | | |
| Predetermined Change
Control Plan Authorized | No | | | | | Device Classification Name | System, Nuclear Magnetic Resonance Imaging | 510(k) Number | K252379 | Device Name | AIR Recon DL | Applicant | | Ge Medical Systems, LLC |
| 3200 N Grandview Blvd. |
| Waukesha, 
WI 
53188 | | Ge Medical Systems, LLC | 3200 N Grandview Blvd. | Waukesha, 
WI 
53188 | Applicant Contact | Derek Schmidtke | Correspondent | | Ge Medical Systems, LLC |
| 3200 N Grandview Blvd. |
| Waukesha, 
WI 
53188 | | Ge Medical Systems, LLC | 3200 N Grandview Blvd. | Waukesha, 
WI 
53188 | Correspondent Contact | Andrew Turner | Regulation Number | 892.1000 | Classification Product Code | | LNH | | LNH | Date Received | 07/30/2025 | Decision Date | 12/23/2025 | Decision | Substantially Equivalent 

(SESE) | Regulation Medical Specialty | Radiology | 510k Review Panel | Radiology | Summary | [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252379.pdf) | Type | Traditional | Reviewed by Third Party | No | Combination Product | No | Predetermined Change

Control Plan Authorized | No | | | | |
| | Device Classification Name | System, Nuclear Magnetic Resonance Imaging | | | |
| --- | --- | | | |
| 510(k) Number | K252379 | | | |
| Device Name | AIR Recon DL | | | |
| Applicant | \| Ge Medical Systems, LLC \|
\| 3200 N Grandview Blvd. \|
\| Waukesha, 
WI 
53188 \| | Ge Medical Systems, LLC | 3200 N Grandview Blvd. | Waukesha, 
WI 
53188 |
| Ge Medical Systems, LLC | | | | |
| 3200 N Grandview Blvd. | | | | |
| Waukesha, 
WI 
53188 | | | | |
| Applicant Contact | Derek Schmidtke | | | |
| Correspondent | \| Ge Medical Systems, LLC \|
\| 3200 N Grandview Blvd. \|
\| Waukesha, 
WI 
53188 \| | Ge Medical Systems, LLC | 3200 N Grandview Blvd. | Waukesha, 
WI 
53188 |
| Ge Medical Systems, LLC | | | | |
| 3200 N Grandview Blvd. | | | | |
| Waukesha, 
WI 
53188 | | | | |
| Correspondent Contact | Andrew Turner | | | |
| Regulation Number | 892.1000 | | | |
| Classification Product Code | \| LNH \| | LNH | | |
| LNH | | | | |
| Date Received | 07/30/2025 | | | |
| Decision Date | 12/23/2025 | | | |
| Decision | Substantially Equivalent 

(SESE) \|  \|  \|  \|

| Regulation Medical Specialty | Radiology | | | |
| 510k Review Panel | Radiology | | | |
| Summary | Summary | | | |
| Type | Traditional | | | |
| Reviewed by Third Party | No | | | |
| Combination Product | No | | | |
| Predetermined Change
Control Plan Authorized | No | | | | | Device Classification Name | System, Nuclear Magnetic Resonance Imaging | 510(k) Number | K252379 | Device Name | AIR Recon DL | Applicant | | Ge Medical Systems, LLC |
| 3200 N Grandview Blvd. |
| Waukesha, 
WI 
53188 | | Ge Medical Systems, LLC | 3200 N Grandview Blvd. | Waukesha, 
WI 
53188 | Applicant Contact | Derek Schmidtke | Correspondent | | Ge Medical Systems, LLC |
| 3200 N Grandview Blvd. |
| Waukesha, 
WI 
53188 | | Ge Medical Systems, LLC | 3200 N Grandview Blvd. | Waukesha, 
WI 
53188 | Correspondent Contact | Andrew Turner | Regulation Number | 892.1000 | Classification Product Code | | LNH | | LNH | Date Received | 07/30/2025 | Decision Date | 12/23/2025 | Decision | Substantially Equivalent 

(SESE) | Regulation Medical Specialty | Radiology | 510k Review Panel | Radiology | Summary | [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252379.pdf) | Type | Traditional | Reviewed by Third Party | No | Combination Product | No | Predetermined Change

Control Plan Authorized | No | | | | | |
| Device Classification Name | System, Nuclear Magnetic Resonance Imaging | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 510(k) Number | K252379 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Device Name | AIR Recon DL | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant | | Ge Medical Systems, LLC |
| 3200 N Grandview Blvd. |
| Waukesha, 
WI 
53188 | | Ge Medical Systems, LLC | 3200 N Grandview Blvd. | Waukesha, 
WI 
53188 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Ge Medical Systems, LLC | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 3200 N Grandview Blvd. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Waukesha, 
WI 
53188 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant Contact | Derek Schmidtke | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent | | Ge Medical Systems, LLC |
| 3200 N Grandview Blvd. |
| Waukesha, 
WI 
53188 | | Ge Medical Systems, LLC | 3200 N Grandview Blvd. | Waukesha, 
WI 
53188 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Ge Medical Systems, LLC | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 3200 N Grandview Blvd. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Waukesha, 
WI 
53188 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent Contact | Andrew Turner | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Regulation Number | 892.1000 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Classification Product Code | | LNH | | LNH | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| LNH | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Date Received | 07/30/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Decision Date | 12/23/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Decision | Substantially Equivalent 

(SESE) |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |

| Regulation Medical Specialty | Radiology | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 510k Review Panel | Radiology | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Summary | Summary | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Type | Traditional | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Reviewed by Third Party | No | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Combination Product | No | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Predetermined Change

Control Plan Authorized | No | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

CFR references

21 CFR 820

Named provisions

510(k) Premarket Notification

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Source

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FDA AI-Enabled Medical Devices fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices
Healthcare & Life Sciences

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Classification

Agency
FDA
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
K252379

Who this affects

Applies to
Manufacturers Medical device makers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Medical Device Clearance
Geographic scope
United States US

Taxonomy

Primary area
Medical Devices
Operational domain
Product Development
Topics
Artificial Intelligence Software as a Medical Device

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