BRIVO MR355, OPTIMA MR360
FDA 510(k) clearance K103330 · decided 2011-02-11
Clearance details
- K-number
- K103330
- Device name
- BRIVO MR355, OPTIMA MR360
- Applicant
- Ge Hangwei Medical Systems Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2010-11-12
- Decision date
- 2011-02-11
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Beijing, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brivo MR355, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magn recall (Z-2477-2024) | GE Medical Systems, LLC | 2024-08-02 |
| Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Mag recall (Z-2478-2024) | GE Medical Systems, LLC | 2024-08-02 |
| Brivo MR355, Optima MR360 Product Usage: The Brivo MR355/Optima MR360 is a whole body magn recall (Z-3021-2017) | GE Medical Systems, LLC | 2017-08-02 |
| GE Healthcare, Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR System, GE 0. recall (Z-1209-2013) | GE Healthcare, LLC | 2013-05-01 |
| 10) Brivo MR355/Optima MR360 Not yet 510(K) cleared and are not distributed in the US. (K1 recall (Z-1433-2011) | GE Healthcare, LLC | 2011-02-24 |