OLYMPUS IMAGEMANAGER SYSTEM
FDA 510(k) clearance K934889 · decided 1994-01-28
Clearance details
- K-number
- K934889
- Device name
- OLYMPUS IMAGEMANAGER SYSTEM
- Applicant
- Olympus
- Decision
- Substantially Equivalent
- Date received
- 1993-10-13
- Decision date
- 1994-01-28
- Days to decision
- 107 days
- Clearance type
- Traditional
- Product code
- LMB
- Device class
- 1
- Regulation number
- 892.2010
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Lake Success, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4.1 (excluding version 6 recall (Z-0047-04) | Olympus America Inc. | 2003-10-15 |
| Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4 --- Common name: Medic recall (Z-1126-03) | Olympus America Inc. | 2003-08-12 |