510(k) · Cleared
Recalled · Class II · 2021GE 1.5T Signa Hde MR 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 Nov 9, 2005 as substantially equivalent to K052293 (Ge Medical Systems, LLC, 2005) after a 16-day review. Its family tree reaches back 5 generations to 1996. 4 of the 20 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it. It has been recalled 5 times.
- Decided
- Nov 9, 2005
- Review
- 16 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 5 generations to K962061 (1996). 11 ancestors in all. 8 later devices descend from it, 1 citing it directly. 4 of the 20 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK962061 Magnetic Resonance Diagnostic SystemGE Medical Systems · 1996 · Recalled
- 4 generations backK012200 1.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · Recalled (Class I)
- 3 generations backK013636 Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · Recalled (Class I)
- 2 generations backK041476 GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC · 2004 · Recalled (Class I)
- 1 generation backK052293 GE 1.5T and 3.0T Signa HDX MR SystemGe Medical Systems, LLC · 2005 · Recalled
- This deviceK052978 GE 1.5T Signa Hde MR SystemGe Medical Systems, LLC · 2005
- Descendant · cites it directly · 7 of its ownK103330 Brivo MR355, Optima MR360Ge Hangwei Medical Systems Co., Ltd. · 2011 · Recalled
- Descendant · 2 generations on · 5 of its ownK123417 Brivo MR355, Optima MR360Ge Hangwei Medical Systems Co., Ltd. · 2013 · Recalled
- Descendant · 3 generations on · 3 of its ownK143251 SIGNA Creator, SIGNA ExplorerGe Healthcare (Ge Medical Systems, LLC) · 2015 · Recalled
- Descendant · 4 generations on · 2 of its ownK211980 SIGNA PrimeGe Healthcare (Tianjin) Company Limited · 2022 · Recalled
- Descendant · 4 generations on · 1 of its ownK223439 SIGNA VictorGe Healthcare (Tianjin) Company Limited · 2023 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K041476 GE Signa Excite 1.5T MR System, GE Signa Excite…2 generations back · 2004
- K030874 GE 3.0T Signa Infinity Twinspeed with Excite MR…3 generations back · 2003
- K013636 Signa Infinity MR System with Excite Technology3 generations back · 2002
- K012200 1.5T Infinity Twinspeed MR System4 generations back · 2001
Most influential descendants
Showing 5 of 8 · See all- K103330Brivo MR355, Optima MR360Ge Hangwei Medical Systems Co., Ltd. · 2011 · cites it directly7descendants
- K123417Brivo MR355, Optima MR360Ge Hangwei Medical Systems Co., Ltd. · 2013 · 2 generations on5descendants
- K143251SIGNA Creator, SIGNA ExplorerGe Healthcare (Ge Medical Systems, LLC) · 2015 · 3 generations on3descendants
- K211980SIGNA PrimeGe Healthcare (Tianjin) Company Limited · 2022 · 4 generations on2descendants
- K223439SIGNA VictorGe Healthcare (Tianjin) Company Limited · 2023 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K962061 | Magnetic Resonance Diagnostic System | GE Medical Systems | 1996 | 2 |
| −4 | K012200 | 1.5T Infinity Twinspeed MR System | GE Medical Systems | 2001 | Class I |
| −3 | K013636 | Signa Infinity MR System with Excite Technology | GE Medical Systems | 2002 | Class I |
| −2 | K041476 | GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System | Ge Medical Systems, LLC | 2004 | Class I |
| −1 | K052293 | GE 1.5T and 3.0T Signa HDX MR System | Ge Medical Systems, LLC | 2005 | 21 |
| 0 (this device) | K052978 | GE 1.5T Signa Hde MR System | Ge Medical Systems, LLC | 2005 | — |
| +1 | K103330 | Brivo MR355, Optima MR360 | Ge Hangwei Medical Systems Co., Ltd. | 2011 | 6 |
| +2 | K123417 | Brivo MR355, Optima MR360 | Ge Hangwei Medical Systems Co., Ltd. | 2013 | 6 |
| +3 | K143251 | SIGNA Creator, SIGNA Explorer | Ge Healthcare (Ge Medical Systems, LLC) | 2015 | 14 |
| +4 | K211980 | SIGNA Prime | Ge Healthcare (Tianjin) Company Limited | 2022 | 2 |
| +4 | K223439 | SIGNA Victor | Ge Healthcare (Tianjin) Company Limited | 2023 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 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.
4 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 |
|---|---|---|---|
| * | K052293 | GE 1.5T and 3.0T Signa HDX MR SystemSummary page 1…, 21 CFR 892.1000, 90-LNH Marketed Device: The 1.5T Signa® HDe MR System is substantially equivalent to the currently marketed GE 1.5T AND 3.OT Signa® HDx MR SYSTEM (K052293) with the main differences being a change to the receive chain architecture that includes fully digital eight independent receiv… | 2005 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103330 | Brivo MR355, Optima MR360 | 2011 | 7 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 23, 2021 | Class II | Z-0609-2022 | Process control | The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| Jun 8, 2012 | Class II | Z-1208-2013 | 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… |
| 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 9, 2010 | Not classified | Z-1427-2011 | 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… |
| 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… |
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.
- K041476GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC · 2004 · 2 generations back · ◆ on the line of descent in 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 · ◆ on the line of descent in FIG. 11 Class I recall
- K0122001.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 7 of the 11 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K103330 (Ge Hangwei Medical Systems Co., Ltd., 2011) has gone furthest, with 7 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.
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® HDe MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa® HDe MR system is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis…
Read the full statement (119 words)
The GE Signa® HDe MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa® HDe MR system is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectra, dynamic images of the internal structures and organs 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. The images produced by the Signa® HDe system reflect the spatial distribution of protons (hydrogen 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/K052978 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052978: GE 1.5T Signa Hde MR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052978
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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