510(k) · Cleared
Recalled · Class II · 2024SIGNAPioneer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Mar 29, 2016 as substantially equivalent to K143345 (Ge Healthcare Japan Corporation, 2015) after a 25-day review. Its family tree reaches back 14 generations to 1997. 5 of the 41 devices in its family, counting itself, have a Class I recall. 9 later devices descend from it. It has been recalled 5 times.
- Decided
- Mar 29, 2016
- Review
- 25 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 14 generations to K971684 (1997). 31 ancestors in all, the oldest K962061 (1996). 9 later devices descend from it, 2 citing it directly. 5 of the 41 devices in this family, counting this one, have a Class I recall.
- Root · 14 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 10 generations between
- 3 generations backK132376 Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T…Ge Healthcare (Ge Medical Systems, LLC) · 2013 · Recalled
- 2 generations backK142085 Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750…Ge Medical Systems, LLC · 2014 · Recalled
- 1 generation backK143345 SIGNA PioneerGe Healthcare Japan Corporation · 2015 · Recalled
- This deviceK160621 SIGNAPioneerGE Healthcare · 2016
- Descendant · cites it directly · 4 of its ownK161567 SIGNA VoyagerGE Healthcare · 2016 · Recalled
- Descendant · cites it directly · 3 of its ownK213668 SIGNA HeroGe Healthcare (Ge Medical Systems, LLC) · 2022 · Recalled
- Descendant · 2 generations on · 1 of its ownK223523 Sonic DLGe Medical Systems,Llc (Ge Healthcare) · 2023
- Descendant · 2 generations on · 1 of its ownK192426 Signa Voyager, Signa Voyager QuantumGe Healthcare (Tianjin) Company Limited · 2019 · Recalled
- Descendant · 2 generations on · 1 of its ownK183621 EMMA 1.5T MRI SystemTime Medical Limited · 2019
Show all 14 generations
- Root · 14 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 13 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 12 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 11 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- 10 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
- 9 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
- 8 generations backK081028 Signa 3.0T MR750 SystemGe Medical Systems, LLC · 2008 · Recalled
- 7 generations backK083147 Discovery MR450Ge Medical Systems, LLC · 2008 · Recalled
- 6 generations backK091536 Optima MR450WGe Medical Systems, LLC · 2009 · Recalled
- 5 generations backK113490 Optima MR450WGe Medical Systems, LLC · 2012 · Recalled
- 4 generations backK123522 Optima MR450WGe Healthcare (Ge Medical Systems, LLC) · 2013 · Recalled
- 3 generations backK132376 Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T…Ge Healthcare (Ge Medical Systems, LLC) · 2013 · Recalled
- 2 generations backK142085 Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750…Ge Medical Systems, LLC · 2014 · Recalled
- 1 generation backK143345 SIGNA PioneerGe Healthcare Japan Corporation · 2015 · Recalled
- This deviceK160621 SIGNAPioneerGE Healthcare · 2016
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 9 · See all- K161567SIGNA VoyagerGE Healthcare · 2016 · cites it directly4descendants
- K213668SIGNA HeroGe Healthcare (Ge Medical Systems, LLC) · 2022 · cites it directly3descendants
- K223523Sonic DLGe Medical Systems,Llc (Ge Healthcare) · 2023 · 2 generations on1descendant
- K192426Signa Voyager, Signa Voyager QuantumGe Healthcare (Tianjin) Company Limited · 2019 · 2 generations on1descendant
- K183621EMMA 1.5T MRI SystemTime Medical Limited · 2019 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −13 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −12 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −11 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −10 | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −9 | K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | 2007 | Class I |
| −8 | K081028 | Signa 3.0T MR750 System | Ge Medical Systems, LLC | 2008 | 11 |
| −7 | K083147 | Discovery MR450 | Ge Medical Systems, LLC | 2008 | 10 |
| −6 | K091536 | Optima MR450W | Ge Medical Systems, LLC | 2009 | 8 |
| −5 | K113490 | Optima MR450W | Ge Medical Systems, LLC | 2012 | 3 |
| −4 | K123522 | Optima MR450W | Ge Healthcare (Ge Medical Systems, LLC) | 2013 | 1 |
| −3 | K132376 | Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T, Optima… | Ge Healthcare (Ge Medical Systems, LLC) | 2013 | 15 |
| −2 | K142085 | Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750 3.0T,Optima MR450W… | Ge Medical Systems, LLC | 2014 | 27 |
| −1 | K143345 | SIGNA Pioneer | Ge Healthcare Japan Corporation | 2015 | 6 |
| 0 (this device) | K160621 | SIGNAPioneer | GE Healthcare | 2016 | — |
| +1 | K161567 | SIGNA Voyager | GE Healthcare | 2016 | 4 |
| +1 | K213668 | SIGNA Hero | Ge Healthcare (Ge Medical Systems, LLC) | 2022 | 2 |
| +2 | K223523 | Sonic DL | Ge Medical Systems,Llc (Ge Healthcare) | 2023 | — |
| +2 | K192426 | Signa Voyager, Signa Voyager Quantum | Ge Healthcare (Tianjin) Company Limited | 2019 | 4 |
| +2 | K183621 | EMMA 1.5T MRI System | Time Medical Limited | 2019 | — |
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 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 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.
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? (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 |
|---|---|---|---|
| * | K143345 | SIGNA PioneerSummary page 5…Device Classification Names: Magnetic Resonance Diagnostic Device per 21 CFR 892.1000 Product Code: LNH Predicate Device: SIGNA Pioneer (K143345) Device Description: The SIGNA Pioneer features a 3.0T superconducting magnet with a 70cm… | 2015 |
What descends from it? (9)
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-2460-2024 | 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… |
| Dec 23, 2021 | Class II | Z-0592-2022 | 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-0134-2022 | 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-2054-2021 | 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-0876-2020 | 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… |
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.
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 7 generations back · ◆ 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 · 8 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K030874GE 3.0T Signa Infinity Twinspeed with Excite MR SystemGeneral Electric Co. · 2003 · 9 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K013636Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · 9 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
- K0122001.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · 10 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 24 of the 31 ancestors have a recall of any class; 5 have a Class I recall.
- Of its descendants, K161567 (GE Healthcare, 2016) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K143345.
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. 2016, 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 SIGNA Pioneer is 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…
Read the full statement (129 words)
The SIGNA Pioneer is 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 SIGNA Pioneer reflect 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/K160621 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160621: SIGNAPioneer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160621
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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