# Mriguidance B.V.

- Location (FDA's records): Utrecht, NL
- FDA decisions: 4 (2021–2026): 4 510(k) clearances
- Product codes: QIH (4)
- 510(k) review time since 2016: median 170 days, against 136 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 4 (2 its own); citations of its devices by later devices: 4 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Mrlguidance B.V.: 1 (https://510kreport.com/company/mrlguidance)
- Subtle Medical, Inc.: 1 (https://510kreport.com/company/subtle-medical)

## Firms that cite its devices most
- Mrlguidance B.V.: 1 (https://510kreport.com/company/mrlguidance)
- MRI2CT, Inc.: 1 (https://510kreport.com/company/mri2ct)

## Its most-cited devices
- K233030: BoneMRI (2024), cited by 2
- K230197: BoneMRI v1.6 (2023), cited by 1
- K202404: BoneMRI (2021), cited by 1

## Recent decisions
- K260584: BoneMRI (Aug 21, 2026)
- K233030: BoneMRI (Mar 1, 2024)
- K230197: BoneMRI v1.6 (Feb 22, 2023)
- K202404: BoneMRI (Dec 22, 2021)

Source page: https://510kreport.com/company/mriguidance