510(k) · Cleared
Recalled · Class I · 2021GE Signa 3.0T with Excite MR System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Electric Co. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Apr 14, 2004 as substantially equivalent to K022397 (GE Medical Systems, 2002) after an 85-day review. Its family tree reaches back 2 generations to 1999. 1 of the 6 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled 10 times, including a Class I recall.
- Decided
- Apr 14, 2004
- Review
- 85 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 10 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 2 generations to K990550 (1999). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK990550 3.0T Signa VH/I Magnetic Resonance SystemGe Medical Systems, Inc. · 1999
- 1 generation backK022397 Signa 3.0T Magnetic Resonance SystemGE Medical Systems · 2002 · Recalled
- This deviceK040444 GE Signa 3.0T with Excite MR SystemGeneral Electric Co. · 2004
- Descendant · cites it directly · 0 of its ownK080820 Tem 3002G- HN Dual Tune Head CoilMr Instruments, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK052200 Tem 3000 Head CoilMr Instruments, Inc. · 2005
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K990550 | 3.0T Signa VH/I Magnetic Resonance System | Ge Medical Systems, Inc. | 1999 | — |
| −1 | K022397 | Signa 3.0T Magnetic Resonance System | GE Medical Systems | 2002 | 1 |
| 0 (this device) | K040444 | GE Signa 3.0T with Excite MR System | General Electric Co. | 2004 | — |
| +1 | K080820 | Tem 3002G- HN Dual Tune Head Coil | Mr Instruments, Inc. | 2008 | — |
| +1 | K052200 | Tem 3000 Head Coil | Mr Instruments, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 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.
1 device in this family has 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 |
|---|---|---|---|
| * | K022397 | Signa 3.0T Magnetic Resonance SystemSummary page 1…2.1000, 90-LNH Marketed Device: The GE Signa® 3.OT with Excite Magnetic Resonance System is substantially equivalent to the currently marketed Signa® 3.OT MR system (K022397) with the main differences being an addition of eight independent receive channels as part of a system upgrade. Device Descrip… | 2002 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 23, 2021 | Class II | Z-0614-2022 | Process control | The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| 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-0256-2016 | 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… |
| Jun 1, 2006 | Not classified | Z-0815-2007 | Other | To provide the 3.0T MRI systems users with the 8-channel brain coil the proper coil weighting software. The proper coil weighting factors for the eight-channel brain coil were not included in the software. |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K080820 (Mr Instruments, Inc., 2008) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K022397.
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® 3.OT with Excite is a whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa® 3.OT with Excite MR 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…
Read the full statement (127 words)
The GE Signa® 3.OT with Excite is a whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa® 3.OT with Excite MR 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® 3.OT with Excite MR 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 as stated in the FDA summary.
https://510kreport.com/device/K040444 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040444: GE Signa 3.0T with Excite 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/K040444
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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