Imvaria, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Imvaria, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Fibresolve (with PCCP), ScreenDx
3
Total
2
Cleared
1
Denied
Imvaria, Inc. has 2 FDA 510(k) cleared medical devices. Based in Berkley, US.
Latest FDA clearance: Nov 2025. Active since 2024. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by Imvaria, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by RQM+ as regulatory consultant. 1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.
FDA 510(k) Regulatory Record - Imvaria, Inc.
3 devices