KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345
FDA 510(k) clearance K051258 · decided 2005-06-01
Clearance details
- K-number
- K051258
- Device name
- KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345
- Applicant
- Eastman Kodak Company
- Decision
- Substantially Equivalent
- Date received
- 2005-05-16
- Decision date
- 2005-06-01
- Days to decision
- 16 days
- Clearance type
- Special
- Product code
- KPR
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Rochester, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Kodak DirectView DR 7500 Diagnostic X-Ray System Product Usage: The DR 7500 system is a pe recall (Z-2177-2014) | Carestream Health, Inc. | 2014-08-10 |
| KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream H recall (Z-0844-2014) | Carestream Health, Inc. | 2014-01-27 |
| DR 7500 with FF WS These products are permanently installed diagnostic x-ray systems compo recall (Z-0798-2014) | Carestream Health, Inc. | 2014-01-21 |
| Kodak Direct View DR7500 System, Catalog #s 855-1046, 879-1345, 161-9139 --- A stationary recall (Z-0738-2007) | Carestream Health, Inc. | 2007-06-30 |