510(k) · Cleared

Recalled · Class II · 2012

GE 0.2T Signa Profile Excite MR System

K043112510(k) SpecialCleared Nov 24, 200414-day reviewClass II21 CFR 892.1000Recalls 1

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

General Electric Co. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Nov 24, 2004 as substantially equivalent to K033168 (General Electric Co., 2003) after a 14-day review. Its family tree reaches back 2 generations to 1999. It has been recalled once.

Decided: Nov 24, 2004
Review: 14 days
Class: Class II
Product code: LNH
Recalls: 1
Predicates: 1

Its longest line of descent runs back 2 generations to K992135 (1999). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK992135 Signa Profile/I Magnetic Resonance SystemGe Medical Systems, Inc. · 1999
1 generation backK033168 GE 0.2T Signa Profile/I MR SystemGeneral Electric Co. · 2003
This deviceK043112 GE 0.2T Signa Profile Excite MR SystemGeneral Electric Co. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K992135	Signa Profile/I Magnetic Resonance System	Ge Medical Systems, Inc.	1999	—
−1	K033168	GE 0.2T Signa Profile/I MR System	General Electric Co.	2003	—
0 (this device)	K043112	GE 0.2T Signa Profile Excite MR System	General Electric Co.	2004	—

FIG. 1 — Lineage of K043112, 1999–2004Source: 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.

Planning a device in LNH? 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? (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	Applicant	Decided	Recalls
*	K033168	GE 0.2T Signa Profile/I MR System Summary page 1 …, 21 CFR 892.1000, 90-LNH Marketed Device: Signa® Profile EXCITE MR System is substantially equivalent to the currently marketed the 0.2T Signa® Profile/i MR system (K033168) with the main differences of EXCITE technology with change of data acquisition hardware, host computer operated by new version…	General Electric Co.	2003	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 8, 2012	Class II	Z-1209-2013	Software design	GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. The axial and coronal reformatted images from a sagittal 3D series (such as with applications of FSPGR-3D T1, BRAVO T1, or CUBE T1) of…

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
None of the 2 ancestors has a recall.

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 (166 words)

The Signa® Profile EXCITE MR system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Signa® Profile EXCITE MR system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body, including, but not limited to, the musculoskeletal, vascular, cardiac, and neuro systems. The images produced by the Signa® Profile EXCITE MR 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.

Due to the 'open' design of the system, the Signa® Profile EXCITE MR system may also be utilized for imaging during interventional procedures when performed with MR compatible devices such as, in-room display and MR safe biopsy needles.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K043112 · printed Nov 6, 2026

Cite this page

510(k) Report. “K043112: GE 0.2T Signa Profile Excite 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/K043112

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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