510(k) · Cleared
Recalled · Class II · 20241.5T Signa HDXT 3.0T Signa HDXT Signa Vibrant
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 20, 2012 as substantially equivalent to K052293 (Ge Medical Systems, LLC, 2005) and 1 other predicate after a 105-day review. Its family tree reaches back 10 generations to 1997. 5 of the 31 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it. It has been recalled 10 times.
- Decided
- Sep 20, 2012
- Review
- 105 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 10
- Predicates
- 2
Its longest line of descent runs back 10 generations to K971684 (1997). 25 ancestors in all, the oldest K962061 (1996). 5 later devices descend from it, 2 citing it directly. 5 of the 31 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 6 generations between
- 3 generations backK083147 Discovery MR450Ge Medical Systems, LLC · 2008 · Recalled
- 2 generations backK091536 Optima MR450WGe Medical Systems, LLC · 2009 · Recalled
- 1 generation backK103327 Discovery MR750W 3.0TGe Healthcare Japan Corporation · 2011 · Recalled
- This deviceK121676 1.5T Signa HDXT 3.0T Signa HDXT Signa VibrantGe Medical Systems, LLC · 2012
- Descendant · cites it directly · 2 of its ownK151212 Ziostation2Qi Imaging, LLC · 2015
- Descendant · cites it directly · 1 of its ownK200327 EvrySynaptive Medical, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK181892 Ziostation2Ziosoft, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK232981 Synq Software Version 1.3Synaptive Medical, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK200315 Ziostation2Ziosoft, Inc. · 2020
Show all 10 generations
- Root · 10 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 9 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 8 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 7 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- 6 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
- 5 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
- 4 generations backK081028 Signa 3.0T MR750 SystemGe Medical Systems, LLC · 2008 · Recalled
- 3 generations backK083147 Discovery MR450Ge Medical Systems, LLC · 2008 · Recalled
- 2 generations backK091536 Optima MR450WGe Medical Systems, LLC · 2009 · Recalled
- 1 generation backK103327 Discovery MR750W 3.0TGe Healthcare Japan Corporation · 2011 · Recalled
- This deviceK121676 1.5T Signa HDXT 3.0T Signa HDXT Signa VibrantGe Medical Systems, LLC · 2012
Class I recalls in this family
Most influential descendants
Showing 5 of 5 · See all- K151212Ziostation2Qi Imaging, LLC · 2015 · cites it directly2descendants
- K200327EvrySynaptive Medical, Inc. · 2020 · cites it directly1descendant
- K181892Ziostation2Ziosoft, Inc. · 2018 · 2 generations on1descendant
- K232981Synq Software Version 1.3Synaptive Medical, Inc. · 2023 · 2 generations on0descendants
- K200315Ziostation2Ziosoft, Inc. · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −9 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −8 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −7 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −6 | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −5 | K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | 2007 | Class I |
| −4 | K081028 | Signa 3.0T MR750 System | Ge Medical Systems, LLC | 2008 | 11 |
| −3 | 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 |
| 0 (this device) | K121676 | 1.5T Signa HDXT 3.0T Signa HDXT Signa Vibrant | Ge Medical Systems, LLC | 2012 | — |
| +1 | K151212 | Ziostation2 | Qi Imaging, LLC | 2015 | — |
| +1 | K200327 | Evry | Synaptive Medical, Inc. | 2020 | — |
| +2 | K181892 | Ziostation2 | Ziosoft, Inc. | 2018 | — |
| +2 | K232981 | Synq Software Version 1.3 | Synaptive Medical, Inc. | 2023 | — |
| +3 | K200315 | Ziostation2 | Ziosoft, Inc. | 2020 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 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.
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…m Classification Names: Magnetic resonance diagnostic device Product Code: LNH Predicate Device(s): l.5T and 3.OT Signa HDx MR System (K052293) Discovery MR75Ow 3.OT (K103327) Device Description: The l.5T Signa HDx family and 3.OT… | 2005 |
| * | K103327 | Discovery MR750W 3.0TSummary page 1…evice Product Code: LNH Predicate Device(s): l.5T and 3.OT Signa HDx MR System (K052293) Discovery MR75Ow 3.OT (K103327) Device Description: The l.5T Signa HDx family and 3.OT Signa HDx family systems are a w… | 2011 |
What descends from it? (5)
2 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 |
|---|---|---|---|---|
| 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… |
| Nov 15, 2018 | Class II | Z-0693-2019 | Software design | Possible incorrect software version loaded. |
| May 11, 2017 | Class II | Z-3028-2017 | Mixed-up of materials/components | Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard. |
| 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… |
The 5 latest of 10 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 · 2 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 3 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 · ◆ 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 15 years and passes through 4 companies; a new generation was cleared every 12 months on median.
- 18 of the 25 ancestors have a recall of any class; 5 have a Class I recall.
- Of its descendants, K151212 (Qi Imaging, LLC, 2015) has gone furthest, with 2 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. 2012, 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 1.5T Signa HDx family and 3.0T Signa HDx family are 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…
Read the full statement (143 words)
The 1.5T Signa HDx family and 3.0T Signa HDx family are 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 1.5T Signa HDx family and 3.0T Signa HDx family reflects 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/K121676 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121676: 1.5T Signa HDXT 3.0T Signa HDXT Signa Vibrant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121676
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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