SIGNA ADVANTAGE SP MAGNETIC RESONANCE SYSTEM
FDA 510(k) clearance K942604 · decided 1995-11-24
Clearance details
- K-number
- K942604
- Device name
- SIGNA ADVANTAGE SP MAGNETIC RESONANCE SYSTEM
- Applicant
- GE Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 1994-06-01
- Decision date
- 1995-11-24
- Days to decision
- 541 days
- Clearance type
- Traditional
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- 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 |
|---|---|---|
| 2) Signa Advantage SP (K942604 Signa Advantage SP MR System) A magnetic resonance diagnost recall (Z-1425-2011) | GE Healthcare, LLC | 2011-02-24 |