Cartesion Prime (PCD-1000A/3) V10.15
FDA 510(k) clearance K231748 · decided 2023-09-12
Clearance details
- K-number
- K231748
- Device name
- Cartesion Prime (PCD-1000A/3) V10.15
- Applicant
- Canon Medical Systems Corporation
- Decision
- Substantially Equivalent
- Date received
- 2023-06-15
- Decision date
- 2023-09-12
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- KPS
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Otawara-Shi, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic im recall (Z-0284-2025) | Canon Medical System, USA, INC. | 2024-11-01 |