Mriguidance B.V. is one of 138 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, BoneMRI v1.6
4
Total
4
Cleared
0
Denied
Mriguidance B.V. has 4 FDA 510(k) cleared medical devices. Based in Utrecht, NL.
Latest FDA clearance: Aug 2026. 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.
Regulatory submissions have been managed by Maxis Medical and Avania CRO Canada. 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.
4 devices