C.CAM-AC
FDA 510(k) clearance K051460 · decided 2005-06-15
Clearance details
- K-number
- K051460
- Device name
- C.CAM-AC
- Applicant
- Danish Diagnostic Development A/S
- Decision
- Substantially Equivalent
- Date received
- 2005-06-03
- Decision date
- 2005-06-15
- Days to decision
- 12 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| CardioMD III (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X- recall (Z-1784-2015) | Philips Medical Systems (Cleveland) Inc | 2015-06-11 |