SIGNA MFO/I MAGNETIC RESONANCE SYSTEM
FDA 510(k) clearance K002611 · decided 2000-10-31
Clearance details
- K-number
- K002611
- Device name
- SIGNA MFO/I MAGNETIC RESONANCE SYSTEM
- Applicant
- GE Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2000-08-22
- Decision date
- 2000-10-31
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- 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 |
|---|---|---|
| Signa Ovation, 0.35T MR Systems (MFO 1-4). Indicated for use as a diagnostic imaging devic recall (Z-0426-2011) | GE Healthcare, LLC | 2010-11-19 |
| Signa MFO/I Magnetic Resonance System, Model Numbers : 2210339, 2262700, 2276937, 2282853, recall (Z-0170-2008) | GE Healthcare | 2007-11-07 |