GE DISCOVERY LS SYSTEM
FDA 510(k) clearance K023988 · decided 2003-02-04
Clearance details
- K-number
- K023988
- Device name
- GE DISCOVERY LS SYSTEM
- Applicant
- GE Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2002-12-02
- Decision date
- 2003-02-04
- Days to decision
- 64 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 |
|---|---|---|
| Performix X-ray Tube - Performix ADV, Performix Ultra, Solarix 630. recall (Z-0306-04) | General Electric Med Systems | 2004-01-08 |