MODEL 3000 NUCLEAR CAMERA
FDA 510(k) clearance K882312 · decided 1988-07-14
Clearance details
- K-number
- K882312
- Device name
- MODEL 3000 NUCLEAR CAMERA
- Applicant
- Ohio Imaging, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-06-03
- Decision date
- 1988-07-14
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- IYX
- Device class
- 1
- Regulation number
- 892.1100
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Cleveland, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Prism 3000S and 3000XP Gamma Camera Systems, Models N210060 and N210335. recall (Z-0563-03) | Philips Medical Systems Inc | 2003-02-21 |