510(k) · Cleared

Cleared

3D ASL

K092925510(k) TraditionalCleared Jan 6, 2010105-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 Jan 6, 2010 as substantially equivalent to K083147 (Ge Medical Systems, LLC, 2008) and 1 other predicate after a 105-day review. Its family tree reaches back 8 generations to 1997. 5 of the 24 devices in its family, counting itself, have a Class I recall.

Decided: Jan 6, 2010
Review: 105 days
Class: Class II
Product code: LNH
Recalls: None
Predicates: 2

Its longest line of descent runs back 8 generations to K971684 (1997). 23 ancestors in all, the oldest K962061 (1996). No later device cites it as a predicate yet. 5 of the 24 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 8 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
7 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
6 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
5 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
4 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
3 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
2 generations backK081028 Signa 3.0T MR750 SystemGe Medical Systems, LLC · 2008 · Recalled
1 generation backK083147 Discovery MR450Ge Medical Systems, LLC · 2008 · Recalled
This deviceK092925 3D ASLGe Medical Systems, LLC · 2010

Class I recalls in this family

K072237 Magnetom Veriodirect predicate · 2007
K041476 GE Signa Excite 1.5T MR System, GE Signa Excite…3 generations back · 2004
K030874 GE 3.0T Signa Infinity Twinspeed with Excite MR…4 generations back · 2003
K013636 Signa Infinity MR System with Excite Technology4 generations back · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−8	K971684	Magnetom Project 047 System (Numaris 3.5 Software)	Siemens Medical Solutions USA, Inc.	1997	4
−7	K032428	Magnetom Avanto MR System	Siemens Medical Solutions USA, Inc.	2003	4
−6	K041112	Magnetom Espree System	Siemens Medical Solutions USA, Inc.	2004	4
−5	K052164	Magnetom Systems with Software Syngo MR 2006A	Siemens Medical Solutions USA, Inc.	2005	—
−4	K062454	Magnetom Systems - I-Class and T-Class Releases	Siemens Medi Cal Solutions, Inc.	2006	—
−3	K072237	Magnetom Verio	Siemens Medical Solutions USA, Inc.	2007	Class I
−2	K081028	Signa 3.0T MR750 System	Ge Medical Systems, LLC	2008	11
−1	K083147	Discovery MR450	Ge Medical Systems, LLC	2008	10
0 (this device)	K092925	3D ASL	Ge Medical Systems, LLC	2010	—

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

FIG. 1 — Lineage of K092925, 1997–2010Source: 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

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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
*	K083147	Discovery MR450 Summary page 1 …/Usual 3D ASL Name: Classification 21 CFR 892.1000 Names: Product Code: 90-LNH Predicate K083 147, Discovery MR450 (GE Medical Systems, LLC) Device(s): K072237, MAGNETOM Verio (Siemens AG) Device…	Ge Medical Systems, LLC	2008	10
*	K072237	Magnetom Verio Summary page 1 …21 CFR 892.1000 Names: Product Code: 90-LNH Predicate K083 147, Discovery MR450 (GE Medical Systems, LLC) Device(s): K072237, MAGNETOM Verio (Siemens AG) Device Arterial Spin Labeling (ASL) is an MR technique using the Desc…	Siemens Medical Solutions USA, Inc.	2007	Class I

Also cleared against K083147: 3 other devices →

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 · Direct predicate · ◆ 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 · 3 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 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
K013636Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · 4 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
K0122001.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · 5 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
16 of the 23 ancestors have a recall of any class; 5 have a Class I recall.
3 other devices also cite its predicate K083147.

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. 2010, 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?

3D ASL is a software option intended for use on GE 1.5T and 3.0T MR systems. It is indicated for magnetic resonance imaging of the brain.

3D ASL allows for generation of maps representing blood flow without the use of an exogenous contrast agent. 3D ASL utilizes water in arterial blood as an endogenous contrast media, to visualize tissue perfusion and evaluate cerebral blood flow (CBF).

When interpreted by a trained physician, images generated by 3D ASL provide information that can be useful in determining a diagnosis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K092925 · printed Nov 4, 2026

Cite this page

510(k) Report. “K092925: 3D ASL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092925

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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