510(k) · Cleared

Cleared

MAGiC

K161397510(k) TraditionalCleared Aug 31, 2016104-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, LLC · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Aug 31, 2016 as substantially equivalent to K142085 (Ge Medical Systems, LLC, 2014) after a 104-day review. Its family tree reaches back 13 generations to 1997. 5 of the 32 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.

Decided: Aug 31, 2016
Review: 104 days
Class: Class II
Product code: LNH
Recalls: None
Predicates: 1

Its longest line of descent runs back 13 generations to K971684 (1997). 30 ancestors in all, the oldest K962061 (1996). 1 later device descends from it, 1 citing it directly. 5 of the 32 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 13 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
9 generations between
3 generations backK123522 Optima MR450WGe Healthcare (Ge Medical Systems, LLC) · 2013 · Recalled
2 generations backK132376 Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T…Ge Healthcare (Ge Medical Systems, LLC) · 2013 · Recalled
1 generation backK142085 Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750…Ge Medical Systems, LLC · 2014 · Recalled
This deviceK161397 MAGiCGe Medical Systems, LLC · 2016
Descendant · cites it directly · 0 of its ownK162943 SyMRISyntheticmr AB · 2017

Show all 13 generations

Root · 13 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
12 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
11 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
10 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
9 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
8 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
7 generations backK081028 Signa 3.0T MR750 SystemGe Medical Systems, LLC · 2008 · Recalled
6 generations backK083147 Discovery MR450Ge Medical Systems, LLC · 2008 · Recalled
5 generations backK091536 Optima MR450WGe Medical Systems, LLC · 2009 · Recalled
4 generations backK113490 Optima MR450WGe Medical Systems, LLC · 2012 · Recalled
3 generations backK123522 Optima MR450WGe Healthcare (Ge Medical Systems, LLC) · 2013 · Recalled
2 generations backK132376 Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T…Ge Healthcare (Ge Medical Systems, LLC) · 2013 · Recalled
1 generation backK142085 Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750…Ge Medical Systems, LLC · 2014 · Recalled
This deviceK161397 MAGiCGe Medical Systems, LLC · 2016

Class I recalls in this family

K072237 Magnetom Verio6 generations back · 2007
K041476 GE Signa Excite 1.5T MR System, GE Signa Excite…7 generations back · 2004
K030874 GE 3.0T Signa Infinity Twinspeed with Excite MR…8 generations back · 2003
K013636 Signa Infinity MR System with Excite Technology8 generations back · 2002

Most influential descendants

Showing 1 of 1 · See all

K162943SyMRISyntheticmr AB · 2017 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−13	K971684	Magnetom Project 047 System (Numaris 3.5 Software)	Siemens Medical Solutions USA, Inc.	1997	4
−12	K032428	Magnetom Avanto MR System	Siemens Medical Solutions USA, Inc.	2003	4
−11	K041112	Magnetom Espree System	Siemens Medical Solutions USA, Inc.	2004	4
−10	K052164	Magnetom Systems with Software Syngo MR 2006A	Siemens Medical Solutions USA, Inc.	2005	—
−9	K062454	Magnetom Systems - I-Class and T-Class Releases	Siemens Medi Cal Solutions, Inc.	2006	—
−8	K072237	Magnetom Verio	Siemens Medical Solutions USA, Inc.	2007	Class I
−7	K081028	Signa 3.0T MR750 System	Ge Medical Systems, LLC	2008	11
−6	K083147	Discovery MR450	Ge Medical Systems, LLC	2008	10
−5	K091536	Optima MR450W	Ge Medical Systems, LLC	2009	8
−4	K113490	Optima MR450W	Ge Medical Systems, LLC	2012	3
−3	K123522	Optima MR450W	Ge Healthcare (Ge Medical Systems, LLC)	2013	1
−2	K132376	Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T, Optima…	Ge Healthcare (Ge Medical Systems, LLC)	2013	15
−1	K142085	Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750 3.0T,Optima MR450W…	Ge Medical Systems, LLC	2014	27
0 (this device)	K161397	MAGiC	Ge Medical Systems, LLC	2016	—
+1	K162943	SyMRI	Syntheticmr AB	2017	—

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
2017	1	0

FIG. 1 — Lineage of K161397, 1997–2017Source: 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.

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K142085	Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750 3.0T,Optima MR450W 1.5T Summary page 4 …edicate Device(s): Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T (K142085) GE Healthcare 510(k) Premarket Notific…	Ge Medical Systems, LLC	2014	27

Also cleared against K142085: 5 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K162943	SyMRI	Syntheticmr AB	2017	0

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 · 6 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 · 7 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 · 8 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
K013636Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · 8 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
K0122001.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · 9 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 11 months on median.
23 of the 30 ancestors have a recall of any class; 5 have a Class I recall.
Of its descendants, K162943 (Syntheticmr AB, 2017) has gone furthest, with 0 descendants of its own.
5 other devices also cite its predicate K142085.

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. 2016, this device’s year, is highlighted.

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?

MAGiC (MAGnetic resonance image Compilation) is a software option based on a combination of acquisition and post processing software that is intended for use on GE imaging platforms. MAGiC generates multiple image contrasts from a single acquisition scan. MAGiC enables post-acquisition image contrast adjustment. MAGiC also allows for the generation of parametric maps for further analysis of MRI acquisition data. MAGiC is indicated for head imaging.

When interpreted by a trained physician, MAGiC images can provide information useful in determining diagnosis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K161397 · printed Nov 4, 2026

Cite this page

510(k) Report. “K161397: MAGiC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K161397

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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