OPTIMA MR450W
FDA 510(k) clearance K091536 · decided 2009-07-17
Clearance details
- K-number
- K091536
- Device name
- OPTIMA MR450W
- Applicant
- Ge Medical Systems, LLC
- Decision
- Substantially Equivalent
- Date received
- 2009-05-26
- Decision date
- 2009-07-17
- Days to decision
- 52 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
- Yes
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ge Medical Systems
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
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 MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with recall (Z-1533-2014) | GE Healthcare, LLC | 2014-05-01 |
| GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discov recall (Z-1480-2014) | GE Healthcare, LLC | 2014-04-21 |
| GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa H recall (Z-1207-2013) | GE Healthcare, LLC | 2013-05-01 |
| Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa V recall (Z-0935-2013) | GE Healthcare, LLC | 2013-03-11 |
| GE Healthcare, 1.5T Optima MR450w Product Usage: The Optima MR450w is a whole body magneti recall (Z-3121-2011) | GE Healthcare, LLC | 2011-09-01 |
| GE Healthcare, Optima MR450w 1.5T MR systems The GE Signa MR750 System is a whole body mag recall (Z-1377-2011) | GE Healthcare, LLC | 2011-02-18 |