510(k) K103330 ยท LNH System, Nuclear Magnetic Resonance Imaging
BRIVO MR355, OPTIMA MR360
| Applicant | Ge Hangwei Medical Systems Co., Ltd., Beijing, CN |
| Decision | Substantially Equivalent, Feb 11, 2011 |
| Received | Nov 12, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103330
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 2, 2024 | GE Medical Systems, LLC Brivo MR355, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Aug 2, 2024 | GE Medical Systems, LLC Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Dec 23, 2021 | GE Healthcare, LLC GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355/Optima MR360 System, nuclear magnetic resonance imaging system. Open, Classified |
LNH | None listed |
| Aug 2, 2017 | GE Medical Systems, LLC Brivo MR355, Optima MR360
Product Usage:
The Brivo MR355/Optima MR360 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan tim Terminated |
LNH | None listed |
| May 1, 2013 | GE Healthcare, LLC GE Healthcare, Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR System, GE 0.2T Signa Profile HD MR System.
Indicated for use as a diagnostic imaging device. Terminated |
LNH | None listed |
| Feb 24, 2011 | GE Healthcare, LLC 10) Brivo MR355/Optima MR360 Not yet 510(K) cleared and are not distributed in the US. (K103330)
The Brivo MR355/ Optima MR360 is a whole body magnetic resonance scanner designed to support high res Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.