AGFA CR50.0
FDA 510(k) clearance K050810 · decided 2005-04-21
Clearance details
- K-number
- K050810
- Device name
- AGFA CR50.0
- Applicant
- Agfa Corp.
- Decision
- Substantially Equivalent
- Date received
- 2005-03-31
- Decision date
- 2005-04-21
- Days to decision
- 21 days
- Clearance type
- Special
- Product code
- MQB
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Greenville, SC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CR DX-S, Image Intensified Fluoroscopic X-ray system. recall (Z-0031-2007) | AGFA Corp. | 2006-10-12 |
| CR DX-S, DX-S, Computed radiography system (Digitizer) recall (Z-0855-06) | AGFA Corp. | 2006-05-09 |