FDA AI-Enabled Medical Devices

FDA SKOUT system K253664 Medical Device Notification

The FDA has published a 510(k) premarket notification for the SKOUT system (K253664). This notification indicates a new medical device has been cleared for market. Further details on the device's specific function and intended use are available through the provided FDA database link.

FDA PeekMed Radiology Software 510(k) Notification

The FDA has published a 510(k) premarket notification for PeekMed web radiology software. This notification indicates that the software has met the requirements for market entry, allowing it to be used by healthcare providers.

FDA ART-Plan+ Medical Device Premarket Notification

The FDA has published a premarket notification (510(k)) for the ART-Plan+ medical device. This notification details the device's compliance with regulatory requirements for market entry. The document is part of the FDA's public database for medical device approvals.

FDA 510(k) Premarket Notification - AIR Recon DL

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.

FDA K253532: TruSPECT Processing Station Submission

The FDA has published a 510(k) premarket notification submission for the TruSPECT Processing Station, identified by K253532. This notification indicates a new device is being reviewed or has been cleared by the FDA.