Exo Imaging is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Exo Imaging - FDA 510(k) Cleared Devices
Recent clearances: AI Platform 2.2 (AIP002), AI Platform 2.0 (AIP002)
2
Total
2
Cleared
0
Denied
Exo Imaging has 2 FDA 510(k) cleared medical devices. Based in Santa Clara, US.
Latest FDA clearance: Feb 2026. Active since 2024. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by Exo Imaging Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Exo, Inc. 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 - Exo Imaging
2 devices