Heartvue.ai, Inc. is one of 12968 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Heartvue.ai, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Heartvue.Proton
1
Total
1
Cleared
0
Denied
Heartvue.ai, Inc. has 1 FDA 510(k) cleared medical devices. Based in Brentwood, US.
Latest FDA clearance: Aug 2026. Active since 2026. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by Heartvue.ai, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Innolitics, LLC 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 - Heartvue.ai, Inc.
1 devices