Medical Device Manufacturer · NL , Utrecht

Mriguidance B.V. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2021

Total

Cleared

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

1-3 of 3

Regulatory Intelligence

PCCP authorized FDA software change control pathway

Regulatory consultant 510(k) submission support ecosystem

Maxis Medical

Regulatory activity signals

510(k) clearance pathway relevance detected

Medical device regulatory intelligence node

Consulting ecosystem involvement present

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 11, 2026

Mriguidance B.V. - FDA 510(k) Cleared Devices

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