510(k) · Cleared
Recalled · Class II · 2020Optima MR450W
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, LLC · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Jul 17, 2009 as substantially equivalent to K083147 (Ge Medical Systems, LLC, 2008) after a 52-day review. Its family tree reaches back 8 generations to 1997. 5 of the 83 devices in its family, counting itself, have a Class I recall. 59 later devices descend from it. It has been recalled 8 times.
- Decided
- Jul 17, 2009
- Review
- 52 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 8
- Predicates
- 1
Its longest line of descent runs back 8 generations to K971684 (1997). 23 ancestors in all, the oldest K962061 (1996). 59 later devices descend from it, 3 citing it directly. 5 of the 83 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 deviceK091536 Optima MR450WGe Medical Systems, LLC · 2009
- Descendant · cites it directly · 52 of its ownK103327 Discovery MR750W 3.0TGe Healthcare Japan Corporation · 2011 · Recalled
- Descendant · cites it directly · 44 of its ownK113490 Optima MR450WGe Medical Systems, LLC · 2012 · Recalled
- Descendant · 2 generations on · 43 of its ownK130115 Discovery MR750W 3.0TGe Medical Systems, LLC · 2013 · Recalled
- Descendant · 2 generations on · 43 of its ownK123522 Optima MR450WGe Healthcare (Ge Medical Systems, LLC) · 2013 · Recalled
- Descendant · 3 generations on · 42 of its ownK132376 Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T…Ge Healthcare (Ge Medical Systems, LLC) · 2013 · Recalled
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 59 · See all- K103327Discovery MR750W 3.0TGe Healthcare Japan Corporation · 2011 · cites it directly52descendants
- K113490Optima MR450WGe Medical Systems, LLC · 2012 · cites it directly44descendants
- K130115Discovery MR750W 3.0TGe Medical Systems, LLC · 2013 · 2 generations on43descendants
- K123522Optima MR450WGe Healthcare (Ge Medical Systems, LLC) · 2013 · 2 generations on43descendants
- K132376Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T, Optima MR450W 1.5TGe Healthcare (Ge Medical Systems, LLC) · 2013 · 3 generations on42descendants
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) | K091536 | Optima MR450W | Ge Medical Systems, LLC | 2009 | — |
| +1 | K103327 | Discovery MR750W 3.0T | Ge Healthcare Japan Corporation | 2011 | 6 |
| +1 | K113490 | Optima MR450W | Ge Medical Systems, LLC | 2012 | 3 |
| +2 | K130115 | Discovery MR750W 3.0T | Ge Medical Systems, LLC | 2013 | 1 |
| +2 | K123522 | Optima MR450W | Ge Healthcare (Ge Medical Systems, LLC) | 2013 | 1 |
| +3 | K132376 | Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T, Optima… | Ge Healthcare (Ge Medical Systems, LLC) | 2013 | 15 |
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 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 5 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 6 | 0 |
| 2021 | 1 | 0 |
| 2022 | 5 | 0 |
| 2023 | 6 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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? (1)
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 |
|---|---|---|---|
| * | K083147 | Discovery MR450Summary page 1…ce Name: Proprietor/Nome: Optima MR450w ClassificationNome: Magnetic Resonance Diagnostic System, 21 CFR 892.1000, 90-LNH Predicate Device: GE Discovery® MR450 System (K083147) Device Description: The 1.5T GE Optima MR450w features a superconducting magnet operating at 1.5 Tesla. The data acquisition sy… | 2008 |
| † | K052293 | GE 1.5T and 3.0T Signa HDX MR System | 2005 |
What descends from it? (59)
See all 593 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 |
|---|---|---|---|---|
| Sep 8, 2020 | Class II | Z-0128-2021 | Process change control | Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet. |
| May 11, 2017 | Class II | Z-3024-2017 | Mixed-up of materials/components | Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard. |
| Apr 23, 2014 | Class II | Z-1533-2014 | Process design | GE Healthcare has recently become aware of a potential safety issue with certain GE MRI Products. Patient egress from the system can be delayed or impeded if the cradle release handle and/or cradle release block mechanism malfunctions or… |
| Apr 2, 2014 | Class II | Z-1480-2014 | Process change control | Potential safety issue with gradient coil electromechanical connections associated with GE MR Products. Gradient coil electromechanical connections may loosen causing an increase in resistance. The increased resistance can lead to… |
| Jun 8, 2012 | Class II | Z-1207-2013 | 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… |
| Jul 29, 2011 | Not classified | Z-3121-2011 | Software design | GE Healthcare has become aware of two potential safety issues associated with MR products (Optima MR450w, Discovery MR450, Discovery MR750, Brivo MR355, Optima MR360) that may impact patient safety. 1) Inline post-processed (i.e.… |
| May 10, 2011 | Class II | Z-0935-2013 | Software design | An error on the SR Viewer Reporting Tool in which edits can be made on a report and can be saved into incorrect reports. |
| Nov 18, 2010 | Not classified | Z-1377-2011 | Nonconforming Material/Component | GE Healthcare has become aware that during certain service procedures, there is a potential for electric shock associated with the gradient cooling manifold hoses of your MR750, MR450, and MR450w MR systems that may impact service or… |
The 5 latest of 8 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 12 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- 16 of the 23 ancestors have a recall of any class; 5 have a Class I recall.
- Of its descendants, K103327 (Ge Healthcare Japan Corporation, 2011) has gone furthest, with 52 descendants of its own.
- 3 other devices also cite its predicate K083147.
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. 2009, 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 Optima MR450w is a whole body magnetic resonance scanner designed to support high resolution and high signal-to-noise ratio images in short exam times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique anatomical images, spectroscopic data, parametric maps, or dynamic images of the structures or functions of the entire body. The indication for use includes, but is not limited to, head, neck, TMJ…
Read the full statement (136 words)
The Optima MR450w is a whole body magnetic resonance scanner designed to support high resolution and high signal-to-noise ratio images in short exam times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique anatomical images, spectroscopic data, parametric maps, or dynamic images of the structures or functions of the entire body. The indication for use includes, but is 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 Optima MR450w reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and 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/K091536 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091536: Optima MR450W.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091536
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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