OPTIMA PET/CT 560
FDA 510(k) clearance K081496 · decided 2008-06-12
Clearance details
- K-number
- K081496
- Device name
- OPTIMA PET/CT 560
- Applicant
- Ge Medical Systems, LLC
- Decision
- Substantially Equivalent
- Date received
- 2008-05-29
- Decision date
- 2008-06-12
- Days to decision
- 14 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
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Discovery PET/CT 610 Product Usage: The systems are intended for head and whole body atten recall (Z-1745-2019) | GE Healthcare, LLC | 2019-06-19 |
| Optima PET/CT 560, 560FX Product Usage: The systems are intended for head and whole body a recall (Z-1747-2019) | GE Healthcare, LLC | 2019-06-19 |
| GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690. The GE D recall (Z-0981-2014) | GE Healthcare, LLC | 2014-02-14 |
| GE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation corr recall (Z-0024-2014) | GE Healthcare, LLC | 2013-10-17 |
| GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Dis recall (Z-1188-2013) | GE Healthcare, LLC | 2013-04-29 |