GENESYS II
FDA 510(k) clearance K922080 · decided 1992-07-17
Clearance details
- K-number
- K922080
- Device name
- GENESYS II
- Applicant
- Adac Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1992-05-04
- Decision date
- 1992-07-17
- Days to decision
- 74 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 |
|---|---|---|
| Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 recall (Z-1598-2015) | Philips Medical Systems (Cleveland) Inc | 2015-05-12 |
| Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic recall (Z-1510-2014) | Philips Medical Systems (Cleveland) Inc | 2014-04-26 |