510(k) · Cleared
Recalled · Class II · 2024Brivo MR355, Optima MR360
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Hangwei Medical Systems Co., Ltd. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Feb 11, 2011 as substantially equivalent to K052978 (Ge Medical Systems, LLC, 2005) and 1 other predicate after a 91-day review. Its family tree reaches back 8 generations to 1997. 5 of the 32 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it. It has been recalled 6 times.
- Decided
- Feb 11, 2011
- Review
- 91 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 6
- Predicates
- 2
Its longest line of descent runs back 8 generations to K971684 (1997). 24 ancestors in all, the oldest K962061 (1996). 7 later devices descend from it, 2 citing it directly. 5 of the 32 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 7 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 6 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 5 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- 4 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
- 3 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
- 2 generations backK081028 Signa 3.0T MR750 SystemGe Medical Systems, LLC · 2008 · Recalled
- 1 generation backK083147 Discovery MR450Ge Medical Systems, LLC · 2008 · Recalled
- This deviceK103330 Brivo MR355, Optima MR360Ge Hangwei Medical Systems Co., Ltd. · 2011
- Descendant · cites it directly · 5 of its ownK123417 Brivo MR355, Optima MR360Ge Hangwei Medical Systems Co., Ltd. · 2013 · Recalled
- Descendant · 2 generations on · 3 of its ownK143251 SIGNA Creator, SIGNA ExplorerGe Healthcare (Ge Medical Systems, LLC) · 2015 · Recalled
- Descendant · 3 generations on · 2 of its ownK211980 SIGNA PrimeGe Healthcare (Tianjin) Company Limited · 2022 · Recalled
- Descendant · 3 generations on · 1 of its ownK223439 SIGNA VictorGe Healthcare (Tianjin) Company Limited · 2023 · Recalled
- Descendant · 4 generations on · 0 of its ownK250379 SIGNA Prime EliteGe Medical Systems, LLC · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 7 · See all- K123417Brivo MR355, Optima MR360Ge Hangwei Medical Systems Co., Ltd. · 2013 · cites it directly5descendants
- K143251SIGNA Creator, SIGNA ExplorerGe Healthcare (Ge Medical Systems, LLC) · 2015 · 2 generations on3descendants
- K211980SIGNA PrimeGe Healthcare (Tianjin) Company Limited · 2022 · 3 generations on2descendants
- K223439SIGNA VictorGe Healthcare (Tianjin) Company Limited · 2023 · 3 generations on1descendant
- K250379SIGNA Prime EliteGe Medical Systems, LLC · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −7 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −6 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −5 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −4 | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −3 | K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | 2007 | Class I |
| −2 | K081028 | Signa 3.0T MR750 System | Ge Medical Systems, LLC | 2008 | 11 |
| −1 | K083147 | Discovery MR450 | Ge Medical Systems, LLC | 2008 | 10 |
| 0 (this device) | K103330 | Brivo MR355, Optima MR360 | Ge Hangwei Medical Systems Co., Ltd. | 2011 | — |
| +1 | K123417 | Brivo MR355, Optima MR360 | Ge Hangwei Medical Systems Co., Ltd. | 2013 | 6 |
| +2 | K143251 | SIGNA Creator, SIGNA Explorer | Ge Healthcare (Ge Medical Systems, LLC) | 2015 | 14 |
| +3 | K211980 | SIGNA Prime | Ge Healthcare (Tianjin) Company Limited | 2022 | 2 |
| +3 | K223439 | SIGNA Victor | Ge Healthcare (Tianjin) Company Limited | 2023 | 1 |
| +4 | K250379 | SIGNA Prime Elite | Ge Medical Systems, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 4 | 1 |
| 2002 | 2 | 1 |
| 2003 | 1 | 1 |
| 2004 | 1 | 1 |
| 2005 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
5 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LNH device
- #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052978 | GE 1.5T Signa Hde MR SystemSummary page 1…MR3SS/Optima MR360 Classification Name: Magnetic Resonance Diagnostic System, 21 CFR 892.1000, 90-LNH Predicate Devices: GE 1.5T Signa® HDe Magnetic Resonance System (K052978) GE Discovery® MR450 System (K083 147) Device Description: The Brivo MR355 / Optima MR360 is a new MR system that is similar in… | 2005 |
| * | K083147 | Discovery MR450Summary page 1…me: Magnetic Resonance Diagnostic System, 21 CFR 892.1000, 90-LNH Predicate Devices: GE 1.5T Signa® HDe Magnetic Resonance System (K052978) GE Discovery® MR450 System (K083 147) Device Description: The Brivo MR355 / Optima MR360 is a new MR system that is similar in design to previous GE Healthcare I ST… | 2008 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 14, 2024 | Class II | Z-2478-2024 | Device Design | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2… |
| Jun 14, 2024 | Class II | Z-2477-2024 | Device Design | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2… |
| Dec 23, 2021 | Class II | Z-0610-2022 | Process control | The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| May 11, 2017 | Class II | Z-3021-2017 | Mixed-up of materials/components | Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard. |
| Jun 8, 2012 | Class II | Z-1209-2013 | Software design | GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. The axial and coronal reformatted images from a sagittal 3D series (such as with applications of FSPGR-3D T1, BRAVO T1, or CUBE T1) of… |
| Nov 9, 2010 | Not classified | Z-1433-2011 | Nonconforming Material/Component | GE Healthcare has become aware of a potential issue associated with the gradient cables being inadvertently swapped while servicing the gradients on some GE Healthcare MR Systems that may impact patient safety. If the gradient cables are… |
The 5 latest of 6 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K041476GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC · 2004 · 3 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K030874GE 3.0T Signa Infinity Twinspeed with Excite MR SystemGeneral Electric Co. · 2003 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K013636Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · 4 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
- K0122001.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · 5 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 17 of the 24 ancestors have a recall of any class; 5 have a Class I recall.
- Of its descendants, K123417 (Ge Hangwei Medical Systems Co., Ltd., 2013) has gone furthest, with 5 descendants of its own.
How does its category compare?
All LNH devicesLNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · LNH
26in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNH
122in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LNH
8in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · LNH
1,263in 2025
MAUDE reports naming product code LNH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 35 | 25 | 114 |
| 2008 | 19 | 53 | 12 | 167 |
| 2009 | 17 | 70 | 7 | 194 |
| 2010 | 12 | 94 | 17 | 165 |
| 2011 | 16 | 81 | 11 | 182 |
| 2012 | 22 | 89 | 5 | 170 |
| 2013 | 19 | 108 | 2 | 107 |
| 2014 | 17 | 108 | 13 | 119 |
| 2015 | 19 | 140 | 12 (2) | 113 |
| 2016 | 20 | 108 | 1 | 135 |
| 2017 | 18 | 98 | 0 | 121 |
| 2018 | 29 | 128 | 71 | 158 |
| 2019 | 26 | 62 | 5 | 158 |
| 2020 | 32 | 121 | 4 | 98 |
| 2021 | 27 | 87 | 41 | 84 |
| 2022 | 30 | 74 | 13 | 138 |
| 2023 | 30 | 124 | 10 (1) | 159 |
| 2024 | 26 | 104 | 4 | 281 |
| 2025 | 26 | 122 | 8 (5) | 1,263 |
| 2026 | 24 | 126 | 43 | — |
What is it indicated for?
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 times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine…
Read the full statement (133 words)
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 times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Brivo MR355/ Optima MR360 reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103330 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103330: Brivo MR355, Optima MR360.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103330
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026