GAMMAMED 12I
FDA 510(k) clearance K891131 · decided 1989-08-07
Clearance details
- K-number
- K891131
- Device name
- GAMMAMED 12I
- Applicant
- Mick Radio-Nuclear Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-03-03
- Decision date
- 1989-08-07
- Days to decision
- 157 days
- Clearance type
- Traditional
- Product code
- JAQ
- Device class
- 2
- Regulation number
- 892.5700
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Bronx, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Varian brand GammaMed 12i Accessory: Clamping adapters for bronchial catheters, 1.8mm diam recall (Z-0329-2012) | Varian Medical Systems, Inc. Oncology Systems | 2011-12-01 |
| Varian brand GammaMed 12i Accessory: Clamping adapters for bronchial catheters, 1.8mm diam recall (Z-0330-2012) | Varian Medical Systems, Inc. Oncology Systems | 2011-12-01 |
| GammaMed 12i radionuclide applicator systems, distributed by Varian Medical Systems, Palo recall (Z-0486-2007) | Varian Medical Systems | 2007-01-11 |
| GammaMed software program, version 5.07, vers. 5.08, vers.-usa, vers.-tst and vers.-row , recall (Z-1398-06) | Varian Medical Systems | 2006-08-10 |