510(k) · Cleared
Recalled · Class II · 2020Discovery MR750W 3.0T
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Healthcare Japan Corporation · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Sep 30, 2011 as substantially equivalent to K081028 (Ge Medical Systems, LLC, 2008) and 1 other predicate after a 322-day review. Its family tree reaches back 9 generations to 1997. 5 of the 77 devices in its family, counting itself, have a Class I recall. 52 later devices descend from it. It has been recalled 6 times.
- Decided
- Sep 30, 2011
- Review
- 322 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 6
- Predicates
- 2
Its longest line of descent runs back 9 generations to K971684 (1997). 24 ancestors in all, the oldest K962061 (1996). 52 later devices descend from it, 3 citing it directly. 5 of the 77 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 5 generations between
- 3 generations backK081028 Signa 3.0T MR750 SystemGe Medical Systems, LLC · 2008 · Recalled
- 2 generations backK083147 Discovery MR450Ge Medical Systems, LLC · 2008 · Recalled
- 1 generation backK091536 Optima MR450WGe Medical Systems, LLC · 2009 · Recalled
- This deviceK103327 Discovery MR750W 3.0TGe Healthcare Japan Corporation · 2011
- Descendant · cites it directly · 43 of its ownK130115 Discovery MR750W 3.0TGe Medical Systems, LLC · 2013 · Recalled
- Descendant · 2 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
- Descendant · 3 generations on · 40 of its ownK142085 Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750…Ge Medical Systems, LLC · 2014 · Recalled
- Descendant · 4 generations on · 16 of its ownK160618 Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T…Ge Medical Systems, LLC · 2016 · Recalled
- Descendant · 5 generations on · 15 of its ownK163331 Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T…Ge Medical Systems, LLC · 2017 · Recalled
Show all 9 generations
- Root · 9 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 8 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 7 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 6 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- 5 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
- 4 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
- 3 generations backK081028 Signa 3.0T MR750 SystemGe Medical Systems, LLC · 2008 · Recalled
- 2 generations backK083147 Discovery MR450Ge Medical Systems, LLC · 2008 · Recalled
- 1 generation backK091536 Optima MR450WGe Medical Systems, LLC · 2009 · Recalled
- This deviceK103327 Discovery MR750W 3.0TGe Healthcare Japan Corporation · 2011
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 52 · See all- K130115Discovery MR750W 3.0TGe Medical Systems, LLC · 2013 · cites it directly43descendants
- K132376Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T, Optima MR450W 1.5TGe Healthcare (Ge Medical Systems, LLC) · 2013 · 2 generations on42descendants
- K142085Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750 3.0T,Optima MR450W 1.5TGe Medical Systems, LLC · 2014 · 3 generations on40descendants
- K160618Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5TGe Medical Systems, LLC · 2016 · 4 generations on16descendants
- K163331Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T…Ge Medical Systems, LLC · 2017 · 5 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −8 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −7 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −6 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −5 | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −4 | K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | 2007 | Class I |
| −3 | K081028 | Signa 3.0T MR750 System | Ge Medical Systems, LLC | 2008 | 11 |
| −2 | K083147 | Discovery MR450 | Ge Medical Systems, LLC | 2008 | 10 |
| −1 | K091536 | Optima MR450W | Ge Medical Systems, LLC | 2009 | 8 |
| 0 (this device) | K103327 | Discovery MR750W 3.0T | Ge Healthcare Japan Corporation | 2011 | — |
| +1 | K130115 | Discovery MR750W 3.0T | Ge Medical Systems, LLC | 2013 | 1 |
| +2 | K132376 | Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T, Optima… | Ge Healthcare (Ge Medical Systems, LLC) | 2013 | 15 |
| +3 | K142085 | Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750 3.0T,Optima MR450W… | Ge Medical Systems, LLC | 2014 | 27 |
| +4 | K160618 | Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima… | Ge Medical Systems, LLC | 2016 | 40 |
| +5 | K163331 | Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery… | Ge Medical Systems, LLC | 2017 | 36 |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 6 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 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 |
|---|---|---|---|
| * | K081028 | Signa 3.0T MR750 SystemSummary page 1…etic Resonance Imaging System Classification Names: Magnetic resonance diagnostic device Product Code: LNH Predicate Device(s): Discovery MR750 (K081028) Optima MR4S0w W1091536) Device Description: The Discovery MR75Ow 3.OT features a superconduct… | 2008 |
| * | K091536 | Optima MR450WSummary page 1…es: Magnetic resonance diagnostic device Product Code: LNH Predicate Device(s): Discovery MR750 (K081028) Optima MR4S0w W1091536) Device Description: The Discovery MR75Ow 3.OT features a superconducting magnet operating at… | 2009 |
What descends from it? (52)
See all 523 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-0127-2021 | Process change control | Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet. |
| Jun 8, 2016 | Class II | Z-2131-2016 | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue with the patient bore heating on the Discovery MR750w. A small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a… |
| 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… |
| 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… |
| Apr 23, 2012 | Class II | Z-1100-2013 | Software design | GE Healthcare has recently become aware of a potential issue due to image flip in frequency encoding direction associated with a specific workflow of your Discovery MR750w system. Image flip issue in frequency encoding direction… |
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 · 2 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 11 months on median.
- 17 of the 24 ancestors have a recall of any class; 5 have a Class I recall.
- Of its descendants, K130115 (Ge Medical Systems, LLC, 2013) has gone furthest, with 43 descendants of its own.
- 1 other device also cites its predicate K081028.
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 Discovery MR750w 3.0T 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 (131 words)
The Discovery MR750w 3.0T 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 Discovery MR750w 3.0T 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/K103327 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103327: Discovery MR750W 3.0T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103327
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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