CAAS Workstation— 510(k) K232147
Substantially EquivalentPie Medical Imaging BV
FDA 510(k) clearance K232147 for CAAS Workstation, Substantially Equivalent on 2024-04-09. Applicant: Pie Medical Imaging BV. Device class: 2.
Clearance details
- Applicant
- Pie Medical Imaging BV
- Product code
- Code QHA
- Device class
- Class 2
- Regulation
- 21 CFR 892.1600
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Maastricht, NL
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