C.CAM
FDA 510(k) clearance K031825 · decided 2003-06-20
Clearance details
- K-number
- K031825
- Device name
- C.CAM
- Applicant
- Danish Diagnostic Development A/S
- Decision
- Substantially Equivalent
- Date received
- 2003-06-13
- Decision date
- 2003-06-20
- Days to decision
- 7 days
- Clearance type
- Abbreviated
- Product code
- KPS
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Horsholm, DK
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| c.cam Gamma Camera, Model No: 9VIR1200; Tomography System (Emission Computed); Siemens Med recall (Z-0304-2008) | Siemens Medical Solutions USA, Inc. | 2007-12-19 |
| c.cam Gamma Camera, Model 9VIR1200; Siemens Medical Solutions USA, Inc., Molecular Imaging recall (Z-0906-2007) | Siemens Medical Solutions USA, Inc. | 2007-06-06 |