Changeflow GovPing Healthcare Variance Amendment - SRS Visual, CDRH
Routine Notice Amended Final

Variance Amendment - SRS Visual, CDRH

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Summary

FDA's Center for Devices and Radiological Health (CDRH) issued a variance amendment related to SRS Visual. The variance was filed under docket FDA-2026-V-2145. The specific regulatory requirements being modified and the scope of the variance cannot be determined from available metadata as the full document content is not accessible.

What changed

FDA CDRH issued an amendment to an existing variance related to SRS Visual, a medical device or radiation-emitting product. The variance modifies specific regulatory requirements applicable to this device under federal standards for electronic products emitting radiation.\n\nManufacturers of similar radiation-emitting devices or software systems should monitor this docket for any precedent-setting variance conditions that may affect their own compliance obligations. The full scope and conditions of this variance are not determinable from available metadata.

What to do next

  1. Monitor regulations.gov for updated document availability
  2. Review variance requirements for radiation-emitting medical devices

Archived snapshot

Apr 14, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

Content

There are no documents available to view or download

Attachments 1

Variance Amendment from SRS Visual

More Information
- Author(s) CDRH
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Last updated

Classification

Agency
FDA
Published
April 14th, 2025
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
FDA-2026-V-2145
Docket
FDA-2026-V-2145

Who this affects

Applies to
Medical device makers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Radiation-emitting devices Medical device compliance
Geographic scope
United States US

Taxonomy

Primary area
Medical Devices
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Product Safety Healthcare

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