CAAS Workstation
FDA 510(k) clearance K232147 · decided 2024-04-09
Clearance details
- K-number
- K232147
- Device name
- CAAS Workstation
- Applicant
- Pie Medical Imaging BV
- Decision
- Substantially Equivalent
- Date received
- 2023-07-19
- Decision date
- 2024-04-09
- Days to decision
- 265 days
- Clearance type
- Traditional
- Product code
- QHA
- Device class
- 2
- Regulation number
- 892.1600
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Maastricht, NL
- Third-party review
- No
- Expedited review
- No
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| X1-FFR (K251355) | Spectrawave, Inc. | 2025-10-17 |
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| AccuICAS (K221711) | ArteryFlow Technology Co., Ltd. | 2023-02-28 |
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| Qangio XA 3D (K182611) | Medis Medical Imaging Systems BV | 2019-05-30 |
Recalls involving this device
No recalls on record reference this clearance.