DEFINIUM 5000 X-RAY SYSTEM
FDA 510(k) clearance K063283 · decided 2006-11-17
Clearance details
- K-number
- K063283
- Device name
- DEFINIUM 5000 X-RAY SYSTEM
- Applicant
- Sedecal., Sa.
- Decision
- Substantially Equivalent
- Date received
- 2006-10-30
- Decision date
- 2006-11-17
- Days to decision
- 18 days
- Clearance type
- Special
- Product code
- MQB
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Deer Field, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Definium 5000 X-ray System, model number 5220493 and 5220393-2 recall (Z-1118-2009) | GE Healthcare, LLC | 2009-09-25 |
| GE Healthcare Definium 5000 Digital Radiographic Imaging System. Model numbers 5220493. Th recall (Z-1133-2008) | GE Healthcare | 2008-09-04 |
| GE Healthcare Definium 5000 Digital Radiographic Imaging System. Model number 5220493-2. T recall (Z-1134-2008) | GE Healthcare | 2008-09-04 |