K233945
- 510(k) number
- K233945
- Device name
- ProxiDiagnost N90 / Precision CRF (706110, 706400)
- Applicant
- Philips Medical Systems Dmc GmbH DE
- Product code
- JAA — System, X-Ray, Fluoroscopic, Image-Intensified
- Decision date
- 2024-01-11
- Date received
- 2023-12-14
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K233945.pdf
Official FDA record: K233945
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.