510(k) · Cleared
Recalled · Class II · 2017Signa 3.0T MR750 System
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 Apr 25, 2008 as substantially equivalent to K052293 (Ge Medical Systems, LLC, 2005) and 1 other predicate after a 14-day review. Its family tree reaches back 6 generations to 1997. 5 of the 92 devices in its family, counting itself, have a Class I recall. 70 later devices descend from it. It has been recalled 11 times.
- Decided
- Apr 25, 2008
- Review
- 14 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 11
- Predicates
- 2
Its longest line of descent runs back 6 generations to K971684 (1997). 21 ancestors in all, the oldest K962061 (1996). 70 later devices descend from it, 2 citing it directly. 5 of the 92 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 5 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 4 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 3 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- 2 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
- 1 generation backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
- This deviceK081028 Signa 3.0T MR750 SystemGe Medical Systems, LLC · 2008
- Descendant · cites it directly · 69 of its ownK083147 Discovery MR450Ge Medical Systems, LLC · 2008 · Recalled
- Descendant · 2 generations on · 59 of its ownK091536 Optima MR450WGe Medical Systems, LLC · 2009 · Recalled
- Descendant · cites it directly · 52 of its ownK103327 Discovery MR750W 3.0TGe Healthcare Japan Corporation · 2011 · Recalled
- Descendant · 3 generations on · 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
Showing 5 of 70 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 70 · See all- K083147Discovery MR450Ge Medical Systems, LLC · 2008 · cites it directly69descendants
- K091536Optima MR450WGe Medical Systems, LLC · 2009 · 2 generations on59descendants
- K103327Discovery MR750W 3.0TGe Healthcare Japan Corporation · 2011 · cites it directly52descendants
- K113490Optima MR450WGe Medical Systems, LLC · 2012 · 3 generations on44descendants
- K130115Discovery MR750W 3.0TGe Medical Systems, LLC · 2013 · 2 generations on43descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −5 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −4 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −3 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −2 | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −1 | K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | 2007 | Class I |
| 0 (this device) | K081028 | Signa 3.0T MR750 System | Ge Medical Systems, LLC | 2008 | — |
| +1 | K083147 | Discovery MR450 | Ge Medical Systems, LLC | 2008 | 10 |
| +2 | K091536 | Optima MR450W | Ge Medical Systems, LLC | 2009 | 8 |
| +1 | K103327 | Discovery MR750W 3.0T | Ge Healthcare Japan Corporation | 2011 | 6 |
| +3 | K113490 | Optima MR450W | Ge Medical Systems, LLC | 2012 | 3 |
| +2 | K130115 | Discovery MR750W 3.0T | Ge Medical Systems, LLC | 2013 | 1 |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 6 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 6 | 0 |
| 2021 | 3 | 0 |
| 2022 | 7 | 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? (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 |
|---|---|---|---|
| * | K052293 | GE 1.5T and 3.0T Signa HDX MR SystemSummary page 1…Device Name: GE 3.OT Signa® MR750 System Magnetic Resonance Diagnostic System, 21 CFR 892.1000, 90-LNH Predicate Devices: GE 3.OT Signa® HDx Magnetic Resonance System 1K0522931 Siemens MAGNETOM Verio 3T Magnetic Resonance System 1K072237) Device Description: The 3.01 GE Signa® MR750 System is a new MR s… | 2005 |
| * | K072237 | Magnetom VerioSummary page 1…Diagnostic System, 21 CFR 892.1000, 90-LNH Predicate Devices: GE 3.OT Signa® HDx Magnetic Resonance System 1K0522931 Siemens MAGNETOM Verio 3T Magnetic Resonance System 1K072237) Device Description: The 3.01 GE Signa® MR750 System is a new MR system that issubstantially equivalent to previously cleared 3.… | 2007 |
What descends from it? (70)
See all 702 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 |
|---|---|---|---|---|
| May 11, 2017 | Class II | Z-3025-2017 | Mixed-up of materials/components | Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard. |
| Dec 7, 2015 | Class II | Z-0201-2019 | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue with the 3.0T 6 Channel Flex Coil used with the 3T MR750W Surgical Suite Scanners. Coil overheating can occur when the device is used in Mode 2 setup. This could lead to… |
| 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… |
| Aug 13, 2013 | Class II | Z-2291-2013 | Component design/selection | GE Healthcare has recently become aware of a potential safety issue due to exposed yellow foam on the end bells of Discovery MR450, Discovery MR750, and Optima MR450w products. The yellow foam strip used between the end bell covers and… |
| Apr 9, 2013 | Class II | Z-2266-2013 | Software design | GE Healthcare has recently become aware of a potential safety issue due to non-unique series identifiers embedded in image headers of certain GE MR Products. For ClariView and Screen Save from GVTK (Gems Visualization ToolKit) Viewer, the… |
| 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-3122-2011 | 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-1375-2011 | 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… |
| Oct 6, 2009 | Not classified | Z-0592-2010 | Software design | GE Healthcare has recently become aware that the use of Confirma, Inc.'s CADstream in conjunction with the GE Healthcare's PURE (Phased Array Uniformity Enhancement) software for dynamic MRI imaging (Signa Excite 1.5T, Signa HD 1.5T… |
The 5 latest of 11 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 · Direct predicate · ◆ 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 · 2 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 · 3 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K013636Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · 3 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
- K0122001.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · 4 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 14 of the 21 ancestors have a recall of any class; 5 have a Class I recall.
- Of its descendants, K083147 (Ge Medical Systems, LLC, 2008) has gone furthest, with 69 descendants of its own.
- 6 other devices also cite its predicate K052293.
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. 2008, 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 GE Signa® MR750 System 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…
Read the full statement (133 words)
The GE Signa® MR750 System 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 GE Signa® MR750 System 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/K081028 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081028: Signa 3.0T MR750 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081028
Report an extraction error
Are you the manufacturer?
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