510(k) · Cleared

Recalled · Class I · 2022

1.5T Infinity Twinspeed MR System

K012200510(k) SpecialCleared Aug 3, 200121-day reviewClass II21 CFR 892.1000Recalls 9 (1 Class I)

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 Aug 3, 2001 as substantially equivalent to K980114 (GE Medical Systems, 1998) and 1 other predicate after a 21-day review. Its family tree reaches back 1 generation to 1996. 3 of the 106 devices in its family, counting itself, have a Class I recall. 103 later devices descend from it. It has been recalled 9 times, including a Class I recall.

Decided: Aug 3, 2001
Review: 21 days
Class: Class II
Product code: LNH
Recalls: 9 (1 Class I)
Predicates: 2

Its longest line of descent runs back 1 generation to K962061 (1996). 2 ancestors in all. 103 later devices descend from it, 2 citing it directly. 3 of the 106 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK962061 Magnetic Resonance Diagnostic SystemGE Medical Systems · 1996 · Recalled
This deviceK012200 1.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001
Descendant · cites it directly · 100 of its ownK013636 Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · Recalled (Class I)
Descendant · 2 generations on · 99 of its ownK041476 GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC · 2004 · Recalled (Class I)
Descendant · 3 generations on · 90 of its ownK052293 GE 1.5T and 3.0T Signa HDX MR SystemGe Medical Systems, LLC · 2005 · Recalled
Descendant · 4 generations on · 70 of its ownK081028 Signa 3.0T MR750 SystemGe Medical Systems, LLC · 2008 · Recalled
Descendant · 4 generations on · 69 of its ownK083147 Discovery MR450Ge Medical Systems, LLC · 2008 · Recalled

Showing 5 of 103 descendants. See all descendants

Descendants cleared per year

2001high 8 (2020) · low 0 (2003)2026

Class I recalls in this family

K013636 Signa Infinity MR System with Excite Technologycites it directly · 2002
K041476 GE Signa Excite 1.5T MR System, GE Signa Excite…2 generations on · 2004

Most influential descendants

Showing 5 of 103 · See all

K013636Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · cites it directly100descendants
K041476GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC · 2004 · 2 generations on99descendants
K052293GE 1.5T and 3.0T Signa HDX MR SystemGe Medical Systems, LLC · 2005 · 3 generations on90descendants
K081028Signa 3.0T MR750 SystemGe Medical Systems, LLC · 2008 · 4 generations on70descendants
K083147Discovery MR450Ge Medical Systems, LLC · 2008 · 4 generations on69descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K962061	Magnetic Resonance Diagnostic System	GE Medical Systems	1996	2
0 (this device)	K012200	1.5T Infinity Twinspeed MR System	GE Medical Systems	2001	—
+1	K013636	Signa Infinity MR System with Excite Technology	GE Medical Systems	2002	Class I
+2	K041476	GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System	Ge Medical Systems, LLC	2004	Class I
+3	K052293	GE 1.5T and 3.0T Signa HDX MR System	Ge Medical Systems, LLC	2005	21
+4	K081028	Signa 3.0T MR750 System	Ge Medical Systems, LLC	2008	11
+4	K083147	Discovery MR450	Ge Medical Systems, LLC	2008	10

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	1	1
2004	1	1
2005	3	0
2007	1	0
2008	3	0
2009	2	0
2010	3	0
2011	4	0
2012	5	0
2013	7	0
2014	6	0
2015	6	0
2016	6	0
2017	6	0
2018	3	0
2019	5	0
2020	8	0
2021	5	0
2022	8	0
2023	7	0
2024	2	0
2025	6	0
2026	4	0

FIG. 1 — Lineage of K012200, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

3 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

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What was it cleared against? (2)

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	Applicant	Decided	Recalls
*	K980114	Magnetic Resonance Diagnostic System Summary page 1 …m, 21 CFR 892.1000, 90-LNH Marketed Device: The Signa 1.5T TwinSpeed System is substantially equivalent to the currently marketed Signa CVMR Magnetic Resonance System (K980114) and the Signa Horizon Cx (K962061). Device Description: The Signa 1.5T TwinSpeed incorporates the Signa Horizon Cx (K962061) a…	GE Medical Systems	1998	—
*	K962061	Magnetic Resonance Diagnostic System Summary page 1 …d Device: The Signa 1.5T TwinSpeed System is substantially equivalent to the currently marketed Signa CVMR Magnetic Resonance System (K980114) and the Signa Horizon Cx (K962061). Device Description: The Signa 1.5T TwinSpeed incorporates the Signa Horizon Cx (K962061) and the Signa CVMR Magnetic Resonanc…	GE Medical Systems	1996	2

What descends from it? (103)

See all 103

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K013636	Signa Infinity MR System with Excite Technology Class I	GE Medical Systems	2002	100
K012970	GE Signa Asset Imaging Option	GE Medical Systems	2001	1

Has anything in its family been recalled? (3 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 18, 2022	Class II	Z-0857-2022	Device Design	There is potential for the images to be flipped left to right.
Dec 23, 2021	Class II	Z-0604-2022	Process control	The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Nov 15, 2018	Class II	Z-0693-2019	Software design	Possible incorrect software version loaded.
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.
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…

The 5 latest of 9 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.

K013636Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · Cites it directly · ◆ in the 2002 descendants bar of FIG. 11 Class I recall
K041476GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC · 2004 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall

What does this lineage say?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K013636 (GE Medical Systems, 2002) has gone furthest, with 100 descendants of its own.

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

2007high 32 (2020) · low 12 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LNH

122in 2025

2007high 140 (2015) · low 35 (2007)2026

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

Recalls per year · LNH

8in 2025

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

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

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?

Read the full statement (104 words)

The Signa 1.5T TwinSpeed Magnetic Resonance System is a whole body scanner designed for shorter scan times. The Signa TwinSpeed 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 TwinSpeed 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.

https://510kreport.com/device/K012200 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012200: 1.5T Infinity Twinspeed 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/K012200

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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