K233030
- 510(k) number
- K233030
- Device name
- BoneMRI
- Applicant
- Mriguidance B.V. NL
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2024-03-01
- Date received
- 2023-09-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K233030.pdf
Official FDA record: K233030
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.