510(k) · Cleared
Recalled · Class II · 2026SIGNA Premier
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 Jul 14, 2017 as substantially equivalent to K163331 (Ge Medical Systems, LLC, 2017) after an 88-day review. Its family tree reaches back 15 generations to 1997. 5 of the 44 devices in its family, counting itself, have a Class I recall. 11 later devices descend from it. It has been recalled 8 times.
- Decided
- Jul 14, 2017
- Review
- 88 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 8
- Predicates
- 1
Its longest line of descent runs back 15 generations to K971684 (1997). 32 ancestors in all, the oldest K962061 (1996). 11 later devices descend from it, 1 citing it directly. 5 of the 44 devices in this family, counting this one, have a Class I recall.
- Root · 15 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 11 generations between
- 3 generations backK142085 Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750…Ge Medical Systems, LLC · 2014 · Recalled
- 2 generations backK160618 Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T…Ge Medical Systems, LLC · 2016 · Recalled
- 1 generation backK163331 Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T…Ge Medical Systems, LLC · 2017 · Recalled
- This deviceK171128 SIGNA PremierGe Medical Systems, LLC · 2017
- Descendant · cites it directly · 10 of its ownK183231 SIGNA PremierGe Medical Systems, LLC · 2019 · Recalled
- Descendant · 2 generations on · 9 of its ownK193282 SIGNA PremierGe Healthcare (Ge Medical Systems, LLC) · 2020 · Recalled
- Descendant · 3 generations on · 2 of its ownK213717 AIR Recon DLGe Medical Systems,Llc (Ge Healthcare) · 2022
- Descendant · 3 generations on · 1 of its ownK251399 SIGNA™ SprintGe Medical Systems, LLC · 2025
- Descendant · 3 generations on · 1 of its ownK201615 Signa 7.0TGe Medical Systems, LLC · 2020 · Recalled
Show all 15 generations
- Root · 15 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 14 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 13 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 12 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- 11 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
- 10 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
- 9 generations backK081028 Signa 3.0T MR750 SystemGe Medical Systems, LLC · 2008 · Recalled
- 8 generations backK083147 Discovery MR450Ge Medical Systems, LLC · 2008 · Recalled
- 7 generations backK091536 Optima MR450WGe Medical Systems, LLC · 2009 · Recalled
- 6 generations backK113490 Optima MR450WGe Medical Systems, LLC · 2012 · Recalled
- 5 generations backK123522 Optima MR450WGe Healthcare (Ge Medical Systems, LLC) · 2013 · Recalled
- 4 generations backK132376 Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T…Ge Healthcare (Ge Medical Systems, LLC) · 2013 · Recalled
- 3 generations backK142085 Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750…Ge Medical Systems, LLC · 2014 · Recalled
- 2 generations backK160618 Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T…Ge Medical Systems, LLC · 2016 · Recalled
- 1 generation backK163331 Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T…Ge Medical Systems, LLC · 2017 · Recalled
- This deviceK171128 SIGNA PremierGe Medical Systems, LLC · 2017
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 11 · See all- K183231SIGNA PremierGe Medical Systems, LLC · 2019 · cites it directly10descendants
- K193282SIGNA PremierGe Healthcare (Ge Medical Systems, LLC) · 2020 · 2 generations on9descendants
- K213717AIR Recon DLGe Medical Systems,Llc (Ge Healthcare) · 2022 · 3 generations on2descendants
- K251399SIGNA™ SprintGe Medical Systems, LLC · 2025 · 3 generations on1descendant
- K201615Signa 7.0TGe Medical Systems, LLC · 2020 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −14 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −13 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −12 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −11 | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −10 | K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | 2007 | Class I |
| −9 | K081028 | Signa 3.0T MR750 System | Ge Medical Systems, LLC | 2008 | 11 |
| −8 | K083147 | Discovery MR450 | Ge Medical Systems, LLC | 2008 | 10 |
| −7 | K091536 | Optima MR450W | Ge Medical Systems, LLC | 2009 | 8 |
| −6 | K113490 | Optima MR450W | Ge Medical Systems, LLC | 2012 | 3 |
| −5 | K123522 | Optima MR450W | Ge Healthcare (Ge Medical Systems, LLC) | 2013 | 1 |
| −4 | K132376 | Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T, Optima… | Ge Healthcare (Ge Medical Systems, LLC) | 2013 | 15 |
| −3 | K142085 | Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750 3.0T,Optima MR450W… | Ge Medical Systems, LLC | 2014 | 27 |
| −2 | K160618 | Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima… | Ge Medical Systems, LLC | 2016 | 40 |
| −1 | K163331 | Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery… | Ge Medical Systems, LLC | 2017 | 36 |
| 0 (this device) | K171128 | SIGNA Premier | Ge Medical Systems, LLC | 2017 | — |
| +1 | K183231 | SIGNA Premier | Ge Medical Systems, LLC | 2019 | 7 |
| +2 | K193282 | SIGNA Premier | Ge Healthcare (Ge Medical Systems, LLC) | 2020 | 7 |
| +3 | K213717 | AIR Recon DL | Ge Medical Systems,Llc (Ge Healthcare) | 2022 | — |
| +3 | K251399 | SIGNA™ Sprint | Ge Medical Systems, LLC | 2025 | — |
| +3 | K201615 | Signa 7.0T | Ge Medical Systems, LLC | 2020 | 1 |
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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K163331 | Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T…Summary page 4…892.1000 Product Code: LNH, LNI, MOS Predicate Device(s): SIGNA™ Architect (K163331) SIGNA Premier--Section 05--Page 3 of 6 GE Healthcar… | 2017 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183231 | SIGNA Premier | 2019 | 10 |
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 27, 2026 | Class II | Z-1767-2026 | Nonconforming Material/Component | Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear and if… |
| Jun 20, 2025 | Class II | Z-2304-2025 | Equipment maintenance | GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA… |
| Jun 14, 2024 | Class II | Z-2462-2024 | 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 24, 2022 | Class II | Z-1430-2022 | Device Design | Under rare conditions, SIGNA Premier gradient coils could result in elevated acoustic noise during scanning. After prolonged periods of elevated acoustic noise, this could potentially lead to hearing loss. |
| Dec 23, 2021 | Class II | Z-0590-2022 | 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-0132-2022 | 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-2052-2021 | 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-0874-2020 | 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… |
The 5 latest of 8 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.
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 8 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 · 9 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 · 10 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K013636Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · 10 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
- K0122001.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · 11 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 25 of the 32 ancestors have a recall of any class; 5 have a Class I recall.
- Of its descendants, K183231 (Ge Medical Systems, LLC, 2019) has gone furthest, with 10 descendants of its own.
- 2 other devices also cite its predicate K163331.
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. 2017, 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(TM) Premier system 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…
Read the full statement (131 words)
The SIGNA(TM) Premier system 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(TM) Premier system 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/K171128 · printed Nov 4, 2026
Cite this page
510(k) Report. “K171128: SIGNA Premier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K171128
Report an extraction error
Are you the manufacturer?
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