LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM
FDA 510(k) clearance K030420 · decided 2003-03-10
Clearance details
- K-number
- K030420
- Device name
- LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM
- Applicant
- GE Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2003-02-10
- Decision date
- 2003-03-10
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- JAK
- Device class
- 2
- Regulation number
- 892.1750
- 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 |
|---|---|---|
| Lightspeed 16 CT recall (Z-2801-2015) | GE Healthcare | 2015-09-21 |
| 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 |
| GE LightSpeed Pro 16 (100kW/80kW) Models 2357739, 2357739-3, 2357739-4, 2357739-6, 2357739 recall (Z-0804-2007) | GE Healthcare | 2007-05-15 |