CIRRUS GAMMA CAMERA
FDA 510(k) clearance K913471 · decided 1991-10-23
Clearance details
- K-number
- K913471
- Device name
- CIRRUS GAMMA CAMERA
- Applicant
- Adac Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1991-08-05
- Decision date
- 1991-10-23
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- KPS
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Milpitas, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ADAC ARGUS Gamma Camera Systems & ADAC CIRRUS Gamma Camera Systems. Distributed by Philips recall (Z-0785-2014) | Philips Medical Systems (Cleveland) Inc | 2014-01-17 |