510(k) · Cleared
ClearedSIGNA™ Bolt
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 Feb 6, 2026 as substantially equivalent to K193282 (Ge Healthcare (Ge Medical Systems, LLC), 2020) after a 72-day review. Its family tree reaches back 18 generations to 1997. 5 of the 36 devices in its family, counting itself, have a Class I recall.
- Decided
- Feb 6, 2026
- Review
- 72 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 18 generations to K971684 (1997). 35 ancestors in all, the oldest K962061 (1996). No later device cites it as a predicate yet. 5 of the 36 devices in this family, counting this one, have a Class I recall.
- Root · 18 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 14 generations between
- 3 generations backK171128 SIGNA PremierGe Medical Systems, LLC · 2017 · Recalled
- 2 generations backK183231 SIGNA PremierGe Medical Systems, LLC · 2019 · Recalled
- 1 generation backK193282 SIGNA PremierGe Healthcare (Ge Medical Systems, LLC) · 2020 · Recalled
- This deviceK253780 SIGNA™ BoltGe Medical Systems, LLC · 2026
Show all 18 generations
- Root · 18 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 17 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 16 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 15 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- 14 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
- 13 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
- 12 generations backK081028 Signa 3.0T MR750 SystemGe Medical Systems, LLC · 2008 · Recalled
- 11 generations backK083147 Discovery MR450Ge Medical Systems, LLC · 2008 · Recalled
- 10 generations backK091536 Optima MR450WGe Medical Systems, LLC · 2009 · Recalled
- 9 generations backK113490 Optima MR450WGe Medical Systems, LLC · 2012 · Recalled
- 8 generations backK123522 Optima MR450WGe Healthcare (Ge Medical Systems, LLC) · 2013 · Recalled
- 7 generations backK132376 Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T…Ge Healthcare (Ge Medical Systems, LLC) · 2013 · Recalled
- 6 generations backK142085 Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750…Ge Medical Systems, LLC · 2014 · Recalled
- 5 generations backK160618 Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T…Ge Medical Systems, LLC · 2016 · Recalled
- 4 generations backK163331 Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T…Ge Medical Systems, LLC · 2017 · Recalled
- 3 generations backK171128 SIGNA PremierGe Medical Systems, LLC · 2017 · Recalled
- 2 generations backK183231 SIGNA PremierGe Medical Systems, LLC · 2019 · Recalled
- 1 generation backK193282 SIGNA PremierGe Healthcare (Ge Medical Systems, LLC) · 2020 · Recalled
- This deviceK253780 SIGNA™ BoltGe Medical Systems, LLC · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −17 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −16 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −15 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −14 | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −13 | K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | 2007 | Class I |
| −12 | K081028 | Signa 3.0T MR750 System | Ge Medical Systems, LLC | 2008 | 11 |
| −11 | K083147 | Discovery MR450 | Ge Medical Systems, LLC | 2008 | 10 |
| −10 | K091536 | Optima MR450W | Ge Medical Systems, LLC | 2009 | 8 |
| −9 | K113490 | Optima MR450W | Ge Medical Systems, LLC | 2012 | 3 |
| −8 | K123522 | Optima MR450W | Ge Healthcare (Ge Medical Systems, LLC) | 2013 | 1 |
| −7 | K132376 | Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T, Optima… | Ge Healthcare (Ge Medical Systems, LLC) | 2013 | 15 |
| −6 | K142085 | Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750 3.0T,Optima MR450W… | Ge Medical Systems, LLC | 2014 | 27 |
| −5 | K160618 | Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima… | Ge Medical Systems, LLC | 2016 | 40 |
| −4 | K163331 | Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery… | Ge Medical Systems, LLC | 2017 | 36 |
| −3 | K171128 | SIGNA Premier | Ge Medical Systems, LLC | 2017 | 8 |
| −2 | K183231 | SIGNA Premier | Ge Medical Systems, LLC | 2019 | 7 |
| −1 | K193282 | SIGNA Premier | Ge Healthcare (Ge Medical Systems, LLC) | 2020 | 7 |
| 0 (this device) | K253780 | SIGNA™ Bolt | Ge Medical Systems, LLC | 2026 | — |
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 |
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 |
|---|---|---|---|
| * | K193282 | SIGNA PremierSummary page 5…nance Diagnostic Device Regulation Number 21 CFR 892.1000 Product Code LNH, LNI, MOS Predicate Device(s) SIGNATM Premier (K193282) Reference Device(s) SIGNATM Victor (K223439) Device Description SIGNATM Bolt is a whole body magnetic resonance sc… | 2020 |
| † | K223439 | SIGNA Victor | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (5 Class I)
No FDA recall names this device.
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 · 11 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 · 12 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 · 13 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K013636Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · 13 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
- K0122001.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · 14 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 29 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 28 of the 35 ancestors have a recall of any class; 5 have a Class I recall.
- 4 other devices also cite its predicate K193282.
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. 2026, 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™ Bolt 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™ Bolt 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™ Bolt 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/K253780 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253780: SIGNA™ Bolt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253780
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