OPTIMA MR 430S
FDA 510(k) clearance K123068 · decided 2012-11-13
Clearance details
- K-number
- K123068
- Device name
- OPTIMA MR 430S
- Applicant
- Ge Medical Systems, LLC
- Decision
- Substantially Equivalent
- Date received
- 2012-10-01
- Decision date
- 2012-11-13
- Days to decision
- 43 days
- Clearance type
- Special
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Wilmington, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Optima 1.5T MR430s MR Scanner, a diagnostic imaging device recall (Z-1928-2016) | GE Healthcare, LLC | 2016-06-08 |