Diagnoly is one of 174 FDA 510(k) medical device manufacturers from France in the dataset, ranked by real submission volume.
Diagnoly - FDA 510(k) Cleared Devices
Recent clearances: FETOLY, FETOLY-HEART
2
Total
2
Cleared
0
Denied
Diagnoly has 2 FDA 510(k) cleared medical devices. Based in Lyon, FR.
Latest FDA clearance: Sep 2025. Active since 2024. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by Diagnoly Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Mcra, 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 - Diagnoly
2 devices