510(k) Report

510(k) · Cleared

Cleared

GE Signa Asset Imaging Option

K012970510(k) SpecialCleared Sep 24, 200120-day reviewClass II21 CFR 892.1000

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

GE Medical Systems · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Sep 24, 2001 as substantially equivalent to K012200 (GE Medical Systems, 2001) and 4 other predicates after a 20-day review. Its family tree reaches back 2 generations to 1996. 1 of the 9 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.

Decided
Sep 24, 2001
Review
20 days
Class
Class II
Product code
LNH
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K962061 (1996). 7 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 9 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors1999: 2 other ancestors1998: 1 other ancestor2016: 1 descendant clearedK962061 · Magnetic Resonance Diagnostic System · GE Medical Systems · 1996 · recalledK012200 · 1.5T Infinity Twinspeed MR System · GE Medical Systems · 2001 · Class I recall1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 1 other ancestor 1 generation forward: 1 descendant K012200 · 1.5T Infinity Twinspeed MR System · GE Medical Systems · 2001 · Class I recallK962061 · Magnetic Resonance Diagnostic System · GE Medical Systems · 1996 · recalled0
  1. Root · 2 generations backK962061 Magnetic Resonance Diagnostic SystemGE Medical Systems · 1996 · Recalled
  2. 1 generation backK012200 1.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · Recalled (Class I)
  3. This deviceK012970 GE Signa Asset Imaging OptionGE Medical Systems · 2001
  4. Descendant · cites it directly · 0 of its ownK162403 HyperBandGe Medical Systems, LLC · 2016

Class I recalls in this family

  • K012200 1.5T Infinity Twinspeed MR Systemdirect predicate · 2001

Most influential descendants

Showing 1 of 1 · See all
  • K162403HyperBandGe Medical Systems, LLC · 2016 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K962061Magnetic Resonance Diagnostic SystemGE Medical Systems19962
−1K0122001.5T Infinity Twinspeed MR SystemGE Medical Systems2001Class I
0 (this device)K012970GE Signa Asset Imaging OptionGE Medical Systems2001—
+1K162403HyperBandGe Medical Systems, LLC2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
199920
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
FIG. 1 — Lineage of K012970, 1996–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K0122001.5T Infinity Twinspeed MR System
Summary page 1
…tion is substantially equivalent to the Array Processor subsystem and reconstruction techniques of the currently marketed Signa 1.5T TwinSpeed Magnetic Resonance System (K012200), Signa VH/i MR System (K990550; K003575; and K006313) and Signa HFO/i MR System (K992746). Device Description: ASSET (Array S…
GE Medical Systems2001Class I
*K9905503.0T Signa VH/I Magnetic Resonance System
Summary page 1
…to the Array Processor subsystem and reconstruction techniques of the currently marketed Signa 1.5T TwinSpeed Magnetic Resonance System (K012200), Signa VH/i MR System (K990550; K003575; and K006313) and Signa HFO/i MR System (K992746). Device Description: ASSET (Array Spatial Sensitivity Encoding Tech…
Ge Medical Systems, Inc.1999—
*K003575Modification to 3.0T Signa VH/I Magnetic Resonance System
Summary page 1
…rray Processor subsystem and reconstruction techniques of the currently marketed Signa 1.5T TwinSpeed Magnetic Resonance System (K012200), Signa VH/i MR System (K990550; K003575; and K006313) and Signa HFO/i MR System (K992746). Device Description: ASSET (Array Spatial Sensitivity Encoding Technique) is…
GE Medical Systems2001—
*K0036133.0.T Signa VH/I (T/R) Body Imaging Coil
Our OCR of the scanned summary read K006313, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Signa VH/i MR System”.
GE Medical Systems2001—
*K992746Signa Hfo/I Magnetic Resonance System
Summary page 1
…ques of the currently marketed Signa 1.5T TwinSpeed Magnetic Resonance System (K012200), Signa VH/i MR System (K990550; K003575; and K006313) and Signa HFO/i MR System (K992746). Device Description: ASSET (Array Spatial Sensitivity Encoding Technique) is an image reconstruction technique used in conjunc…
Ge Medical Systems, Inc.19992

Also cleared against K012200: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K162403HyperBandGe Medical Systems, LLC20160

Has anything in its family been recalled? (1 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.

  • K0122001.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 4.7 years on median.
  • 3 of the 7 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K162403 (Ge Medical Systems, LLC, 2016) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K012200.

How does its category compare?

All LNH devices

LNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LNH

26in 2025

2007: 122008: 192009: 172010: 122011: 162012: 222013: 192014: 172015: 192016: 202017: 182018: 292019: 262020: 322021: 272022: 302023: 302024: 262025: 262026 (partial year): 24
2007high 32 (2020) · low 12 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LNH

122in 2025

2007: 35 days median2008: 53 days median2009: 70 days median2010: 94 days median2011: 81 days median2012: 89 days median2013: 108 days median2014: 108 days median2015: 140 days median2016: 108 days median2017: 98 days median2018: 128 days median2019: 62 days median2020: 121 days median2021: 87 days median2022: 74 days median2023: 124 days median2024: 104 days median2025: 122 days median2026 (partial year): 126 days median
2007high 140 (2015) · low 35 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LNH

8in 2025

2007: 252008: 122009: 72010: 172011: 112012: 52013: 22014: 132015: 12, 2 Class I2016: 12018: 712019: 52020: 42021: 412022: 132023: 10, 1 Class I2024: 42025: 8, 5 Class I2026 (partial year): 43
2007high 71 (2018) · low 0 (2017)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · LNH

1,263in 2025

2007: 1142008: 1672009: 1942010: 1652011: 1822012: 1702013: 1072014: 1192015: 1132016: 1352017: 1212018: 1582019: 1582020: 982021: 842022: 1382023: 1592024: 2812025: 1,263
2007high 1,263 (2025) · low 84 (2021)2025

MAUDE reports naming product code LNH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007123525114
2008195312167
200917707194
2010129417165
2011168111182
201222895170
2013191082107
20141710813119
20151914012 (2)113
2016201081135
201718980121
20182912871158
201926625158
202032121498
202127874184
2022307413138
20233012410 (1)159
2024261044281
2025261228 (5)1,263
20262412643—

What is it indicated for?

The Signa Magnetic Resonance System is a whole body scanner. The Signa Magnetic Resonance System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by the Signa Magnetic Resonance System reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K012200

1 other device cites the same predicate.

  • K013636Signa Infinity MR System with Excite TechnologyGE Medical Systems · 20021 Class I recall

More from GE Medical Systems

170 FDA decisions under this applicant name. See the company

  • K253808AIR Recon DLGE Medical Systems · 2026
  • K220848Venue FitGE Medical Systems · 20221 recall
  • K220851VenueGE Medical Systems · 2022
  • K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems · 20173 recalls
  • K103411Ideal IQ Software OptionGE Medical Systems · 2011

Recent decisions in LNH

The LNH category page

  • K262902ECHELON SynergyFujifilm Corporation · 2026
  • K260092Vista AI ScanVista AI, Inc. · 2026
  • K261612SwiftSight-BodyCompositionAirs Medical, Inc. · 2026
  • K261283APERTO Lucent MRI SystemFujifilm Corporation · 2026
  • K261758Embrace Vision Neonatal MRI SystemAspect Imaging, Ltd. · 2026

https://510kreport.com/device/K012970 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012970: GE Signa Asset Imaging Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012970

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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