K232147
- 510(k) number
- K232147
- Device name
- CAAS Workstation
- Applicant
- Pie Medical Imaging BV NL
- Product code
- QHA — X-Ray Angiographic Imaging Based Coronary Vascular S
- Decision date
- 2024-04-09
- Date received
- 2023-07-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K232147.pdf
Official FDA record: K232147
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.