OPTIMA MR450W
FDA 510(k) clearance K123522 · decided 2013-03-13
Clearance details
- K-number
- K123522
- Device name
- OPTIMA MR450W
- Applicant
- Ge Healthcare (Ge Medical Systems, LLC)
- Decision
- Substantially Equivalent
- Date received
- 2012-11-15
- Decision date
- 2013-03-13
- Days to decision
- 118 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 |
|---|---|---|
| Optima MR450w 1.5T Product Usage: The Optima MR450w 1.5T system is a whole body magnetic r recall (Z-3024-2017) | GE Medical Systems, LLC | 2017-08-02 |