510(k) · Cleared
Recalled · Class I · 2021Signa Infinity MR System with Excite Technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Jan 24, 2002 as substantially equivalent to K012200 (GE Medical Systems, 2001) after an 80-day review. Its family tree reaches back 2 generations to 1996. 3 of the 104 devices in its family, counting itself, have a Class I recall. 100 later devices descend from it. It has been recalled 12 times, including a Class I recall.
- Decided
- Jan 24, 2002
- Review
- 80 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 12 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 2 generations to K962061 (1996). 3 ancestors in all. 100 later devices descend from it, 1 citing it directly. 3 of the 104 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK962061 Magnetic Resonance Diagnostic SystemGE Medical Systems · 1996 · Recalled
- 1 generation backK012200 1.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · Recalled (Class I)
- This deviceK013636 Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002
- Descendant · cites it directly · 99 of its ownK041476 GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC · 2004 · Recalled (Class I)
- Descendant · 2 generations on · 90 of its ownK052293 GE 1.5T and 3.0T Signa HDX MR SystemGe Medical Systems, LLC · 2005 · Recalled
- Descendant · 3 generations on · 70 of its ownK081028 Signa 3.0T MR750 SystemGe Medical Systems, LLC · 2008 · Recalled
- Descendant · 3 generations on · 69 of its ownK083147 Discovery MR450Ge Medical Systems, LLC · 2008 · Recalled
- Descendant · 4 generations on · 59 of its ownK091536 Optima MR450WGe Medical Systems, LLC · 2009 · Recalled
Showing 5 of 100 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 100 · See all- K041476GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC · 2004 · cites it directly99descendants
- K052293GE 1.5T and 3.0T Signa HDX MR SystemGe Medical Systems, LLC · 2005 · 2 generations on90descendants
- K081028Signa 3.0T MR750 SystemGe Medical Systems, LLC · 2008 · 3 generations on70descendants
- K083147Discovery MR450Ge Medical Systems, LLC · 2008 · 3 generations on69descendants
- K091536Optima MR450WGe Medical Systems, LLC · 2009 · 4 generations on59descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K962061 | Magnetic Resonance Diagnostic System | GE Medical Systems | 1996 | 2 |
| −1 | K012200 | 1.5T Infinity Twinspeed MR System | GE Medical Systems | 2001 | Class I |
| 0 (this device) | K013636 | Signa Infinity MR System with Excite Technology | GE Medical Systems | 2002 | — |
| +1 | K041476 | GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System | Ge Medical Systems, LLC | 2004 | Class I |
| +2 | K052293 | GE 1.5T and 3.0T Signa HDX MR System | Ge Medical Systems, LLC | 2005 | 21 |
| +3 | K081028 | Signa 3.0T MR750 System | Ge Medical Systems, LLC | 2008 | 11 |
| +3 | K083147 | Discovery MR450 | Ge Medical Systems, LLC | 2008 | 10 |
| +4 | K091536 | Optima MR450W | Ge Medical Systems, LLC | 2009 | 8 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 1 |
| 2005 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 5 | 0 |
| 2013 | 7 | 0 |
| 2014 | 6 | 0 |
| 2015 | 6 | 0 |
| 2016 | 5 | 0 |
| 2017 | 6 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 8 | 0 |
| 2021 | 5 | 0 |
| 2022 | 8 | 0 |
| 2023 | 7 | 0 |
| 2024 | 2 | 0 |
| 2025 | 6 | 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.
3 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 |
|---|---|---|---|
| * | K012200 | 1.5T Infinity Twinspeed MR SystemSummary page 1…Diagnostic System, 21 CFR 892.1000, 90-LNH Marketed Device: The Signa Infinity System is substantially equivalent to the currently marketed Signa TwinSpeed MR system (K012200) with the main differences being an addition of eight independent receive channels and an update of the technology used for the C… | 2001 |
| † | K012970 | GE Signa Asset Imaging Option | 2001 |
What descends from it? (100)
See all 1001 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041476 | GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System Class I | 2004 | 99 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 23, 2021 | Class II | Z-0605-2022 | Process control | The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| Nov 15, 2018 | Class II | Z-0693-2019 | Software design | Possible incorrect software version loaded. |
| 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. |
| Aug 31, 2015 | Class II | Z-0255-2016 | 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… |
| Jul 10, 2015 | Class II | Z-2339-2015 | Nonconforming Material/Component | A gradient cable in the ACGD cabinet may be missing a spacer that prevents connecting the gradient cable terminals in the wrong polarity on X gradient amplifier. This could cause images to be flipped left-right with incorrect orientation… |
| Mar 9, 2015 | Class II | Z-1305-2015 | Software Manufacturing/Software Deployment | GE Healthcare has become aware of a potential safety issue involving MRI systems due to software versions not being maintained properly at some sites. |
| Jan 7, 2015 | Class I | Z-1035-2015 | Employee error | At certain sites, the MRU may not be connected to the magnet. In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries. The MRU must be… |
| 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… |
| Nov 9, 2010 | Not classified | Z-1432-2011 | 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… |
| May 11, 2009 | Not classified | Z-0462-2011 | Software design | Signa MR Excite" 1.5T system containing 11.1_M4_0818.a software, associated with 2D Fast Spin Echo based pulse sequences (2D FSE-XL, 2D FRFSE-XL, 2D FSE-IR, 2D T2FLAIR and 2D T1FLAIR) may experience an image flip along the phase encode… |
The 5 latest of 12 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.
- K0122001.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · 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 · Cites it directly · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 6 years and passes through 1 company; a new generation was cleared every 4.7 years on median.
- 2 of the 3 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K041476 (Ge Medical Systems, LLC, 2004) has gone furthest, with 99 descendants of its own.
- 1 other device also cites its predicate K012200.
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 Infinity line of products are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa Infinity System is indicated for use as a diagnostic imaging device to produce transverse, 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…
Read the full statement (121 words)
The GE Signa Infinity line of products are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa Infinity System is indicated for use as a diagnostic imaging device to produce transverse, 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 Infinity systems 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013636 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013636: Signa Infinity MR System with Excite Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013636
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026