OPTIMA MR450W
FDA 510(k) clearance K113490 · decided 2012-01-13
Clearance details
- K-number
- K113490
- Device name
- OPTIMA MR450W
- Applicant
- Ge Medical Systems, LLC
- Decision
- Substantially Equivalent
- Date received
- 2011-11-23
- Decision date
- 2012-01-13
- Days to decision
- 51 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 |
| GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 1.5T . scanne recall (Z-2291-2013) | GE Healthcare, LLC | 2013-09-27 |
| GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model recall (Z-2266-2013) | GE Healthcare, LLC | 2013-09-23 |