MODIFICATION TO GE DISCOVERY LS SYSTEM
FDA 510(k) clearance K040172 · decided 2004-04-07
Clearance details
- K-number
- K040172
- Device name
- MODIFICATION TO GE DISCOVERY LS SYSTEM
- Applicant
- GE Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2004-01-26
- Decision date
- 2004-04-07
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- KPS
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Milwaukee, 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 |
| PET Discovery LS recall (Z-2802-2015) | GE Healthcare | 2015-09-21 |