K232007
- 510(k) number
- K232007
- Device name
- CAAS MR Solutions
- Applicant
- Pie Medical Imaging BV NL
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2024-02-01
- Date received
- 2023-07-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K232007.pdf
Official FDA record: K232007
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.