Mriguidance B.V. is one of 68 FDA 510(k) medical device manufacturers from Netherlands in the dataset, ranked by real submission volume.
Mriguidance B.V. - FDA 510(k) Cleared Devices
Recent clearances: BoneMRI, BoneMRI v1.6, BoneMRI
3
Total
3
Cleared
0
Denied
Mriguidance B.V. has 3 FDA 510(k) cleared medical devices. Based in Utrecht, NL.
Latest FDA clearance: Mar 2024. Active since 2021. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by Mriguidance B.V. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Maxis Medical 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 - Mriguidance B.V.
3 devices