DISCOVERY PET/CT 710
FDA 510(k) clearance K133657 · decided 2014-03-21
Clearance details
- K-number
- K133657
- Device name
- DISCOVERY PET/CT 710
- Applicant
- Ge Medical Systems, LLC
- Decision
- Substantially Equivalent
- Date received
- 2013-11-27
- Decision date
- 2014-03-21
- Days to decision
- 114 days
- Clearance type
- Traditional
- Product code
- KPS
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Waukesha, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Discovery PET/CT 710 Product Usage: The systems are intended for head and whole body atten recall (Z-1746-2019) | GE Healthcare, LLC | 2019-06-19 |
| Discovery Ml DR Product Usage: The systems are intended for head and whole body attenuatio recall (Z-1750-2019) | GE Healthcare, LLC | 2019-06-19 |