510(k) · Cleared
Recalled · Class II · 2024GE 1.5T and 3.0T Signa HDX 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 Sep 21, 2005 as substantially equivalent to K041476 (Ge Medical Systems, LLC, 2004) after a 29-day review. Its family tree reaches back 4 generations to 1996. 4 of the 101 devices in its family, counting itself, have a Class I recall. 90 later devices descend from it. It has been recalled 21 times.
- Decided
- Sep 21, 2005
- Review
- 29 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 21
- Predicates
- 1
Its longest line of descent runs back 4 generations to K962061 (1996). 10 ancestors in all. 90 later devices descend from it, 7 citing it directly. 4 of the 101 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK962061 Magnetic Resonance Diagnostic SystemGE Medical Systems · 1996 · Recalled
- 3 generations backK012200 1.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · Recalled (Class I)
- 2 generations backK013636 Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · Recalled (Class I)
- 1 generation backK041476 GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC · 2004 · Recalled (Class I)
- This deviceK052293 GE 1.5T and 3.0T Signa HDX MR SystemGe Medical Systems, LLC · 2005
- Descendant · cites it directly · 70 of its ownK081028 Signa 3.0T MR750 SystemGe Medical Systems, LLC · 2008 · Recalled
- 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 · 2 generations on · 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
Showing 5 of 90 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…direct predicate · 2004
- K030874 GE 3.0T Signa Infinity Twinspeed with Excite MR…2 generations back · 2003
- K013636 Signa Infinity MR System with Excite Technology2 generations back · 2002
- K012200 1.5T Infinity Twinspeed MR System3 generations back · 2001
Most influential descendants
Showing 5 of 90 · See all- K081028Signa 3.0T MR750 SystemGe Medical Systems, LLC · 2008 · cites it directly70descendants
- 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 · 2 generations on52descendants
- K113490Optima MR450WGe Medical Systems, LLC · 2012 · 3 generations on44descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K962061 | Magnetic Resonance Diagnostic System | GE Medical Systems | 1996 | 2 |
| −3 | K012200 | 1.5T Infinity Twinspeed MR System | GE Medical Systems | 2001 | Class I |
| −2 | K013636 | Signa Infinity MR System with Excite Technology | GE Medical Systems | 2002 | Class I |
| −1 | K041476 | GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System | Ge Medical Systems, LLC | 2004 | Class I |
| 0 (this device) | K052293 | GE 1.5T and 3.0T Signa HDX MR System | Ge Medical Systems, LLC | 2005 | — |
| +1 | K081028 | Signa 3.0T MR750 System | Ge Medical Systems, LLC | 2008 | 11 |
| +1 | K083147 | Discovery MR450 | Ge Medical Systems, LLC | 2008 | 10 |
| +2 | K091536 | Optima MR450W | Ge Medical Systems, LLC | 2009 | 8 |
| +2 | K103327 | Discovery MR750W 3.0T | Ge Healthcare Japan Corporation | 2011 | 6 |
| +3 | K113490 | Optima MR450W | Ge Medical Systems, LLC | 2012 | 3 |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 5 | 0 |
| 2013 | 7 | 0 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 8 | 0 |
| 2021 | 4 | 0 |
| 2022 | 8 | 0 |
| 2023 | 7 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 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.
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 |
|---|---|---|---|
| * | K041476 | GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemSummary page 1…ic System, 21 CFR 892.1000, 90-LNH Marketed Device: The 1.5T Signa® H~x MR System is substantially equivalent to the currently marketed Signa® Excite 1.5T MR system (K041476) with the main differences being a change to the receive chain architecture that includes thirty two independent receive channel… | 2004 |
What descends from it? (90)
See all 907 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081028 | Signa 3.0T MR750 System | 2008 | 70 |
| K083147 | Discovery MR450 | 2008 | 69 |
| K072998 | Ideal Software Option for GE MR Scanners | 2007 | 8 |
| K052978 | GE 1.5T Signa Hde MR System | 2005 | 8 |
| K121676 | 1.5T Signa HDXT 3.0T Signa HDXT Signa Vibrant | 2012 | 5 |
| K083421 | MR-Touch Option | 2009 | 4 |
| K081916 | GE Signa MR Oncology Package | 2008 | 3 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 14, 2024 | Class II | Z-2463-2024 | 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-2471-2024 | 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… |
| Feb 18, 2022 | Class II | Z-0860-2022 | Device Design | There is potential for the images to be flipped left to right. |
| Dec 23, 2021 | Class II | Z-0603-2022 | Process control | The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| Aug 26, 2021 | Class II | Z-0141-2022 | Software design | Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images. |
| Jun 4, 2021 | Class II | Z-2065-2021 | Software design | GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed… |
| Dec 23, 2019 | Class II | Z-0877-2020 | Software design | It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. The system s date and time setting are used to populate the DICOM header information on images. This could result is an… |
| Jun 7, 2018 | Class II | Z-0112-2019 | Software change control | The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be patient data mismatch. |
| Jun 7, 2018 | Class II | Z-0110-2019 | Software change control | The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be patient data mismatch. |
| Jun 7, 2018 | Class II | Z-0111-2019 | Software change control | The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be patient data mismatch. |
| May 11, 2017 | Class II | Z-3027-2017 | Mixed-up of materials/components | Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard. |
| Aug 31, 2015 | Class II | Z-0258-2016 | Software design | When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could… |
| Aug 31, 2015 | Class II | Z-0259-2016 | Software design | When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could… |
| 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… |
| Nov 21, 2011 | Class II | Z-1943-2013 | Software design | Screen save images are included in wrong exam due to duplicate UID creation. This may cause a safety issue due to a potential patient data mismatch.While the issue has only been observed at one customer site on the Signa HDxT 1.5T system… |
| 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-1428-2011 | 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… |
| Mar 28, 2008 | Not classified | Z-2225-2008 | Software change control | Possible misdiagnosis or inappropriate treatment based on the image. Signal homogeneity may be affected when BRAVO applications are set with IR Prep off. The concern is that signal inhomogeneity can result in an erroneous diagnosis. |
| Dec 14, 2007 | Not classified | Z-1890-2008 | Software design | GE healthcare has become aware of an artifact which could affect the diagnostic capability associated with the 3.0T Propeller T2 Flair application of the 3.0T Signa HDx scanner. |
| Oct 1, 2007 | Not classified | Z-2210-2008 | Software design | A software issue that may result in misregistration of functional and anatomical images associated with the 3.0T BrainwaveRT fMRI Application on the 3.0T Signa HDx scanner. |
The 5 latest of 21 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.
- K041476GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC · 2004 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K030874GE 3.0T Signa Infinity Twinspeed with Excite MR SystemGeneral Electric Co. · 2003 · 2 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K013636Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K0122001.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · 3 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 2.4 years on median.
- 6 of the 10 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K081028 (Ge Medical Systems, LLC, 2008) has gone furthest, with 70 descendants of its own.
- 2 other devices also cite its predicate K041476.
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® HDx 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® HDx MR system is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine…
Read the full statement (123 words)
The GE Signa® HDx 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® HDx MR system is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectroscopic images, and/or 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 e HDx 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/K052293 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052293: GE 1.5T and 3.0T Signa HDX MR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052293
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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