510(k) · Cleared

Recalled · Class II · 2016

MSK Extreme MR Scanner, Model AA5000

K080048510(k) SpecialCleared Feb 6, 200829-day reviewClass II21 CFR 892.1000Recalls 3

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

Oni Medical Systems, Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Feb 6, 2008 as substantially equivalent to K001773 (Oni, Inc., 2000) and 2 other predicates after a 29-day review. Its family tree reaches back 4 generations to 1997. 2 of the 15 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 3 times.

Decided: Feb 6, 2008
Review: 29 days
Class: Class II
Product code: LNH
Recalls: 3
Predicates: 3

Its longest line of descent runs back 4 generations to K971684 (1997). 12 ancestors in all. 2 later devices descend from it, 1 citing it directly. 2 of the 15 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 4 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
3 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
2 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
1 generation backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
This deviceK080048 MSK Extreme MR Scanner, Model AA5000Oni Medical Systems, Inc. · 2008
Descendant · cites it directly · 1 of its ownK103238 1.5T Optima MR430SGe Medical Systems, LLC · 2011 · Recalled
Descendant · 2 generations on · 0 of its ownK123068 Optima MR 430SGe Medical Systems, LLC · 2012 · Recalled

Class I recalls in this family

K052013 Achieva 1.5T & Inera 1.5T Familydirect predicate · 2005
K043147 Achieva Family2 generations back · 2005

Most influential descendants

Showing 2 of 2 · See all

K1032381.5T Optima MR430SGe Medical Systems, LLC · 2011 · cites it directly1descendant
K123068Optima MR 430SGe Medical Systems, LLC · 2012 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K971684	Magnetom Project 047 System (Numaris 3.5 Software)	Siemens Medical Solutions USA, Inc.	1997	4
−3	K032428	Magnetom Avanto MR System	Siemens Medical Solutions USA, Inc.	2003	4
−2	K041112	Magnetom Espree System	Siemens Medical Solutions USA, Inc.	2004	4
−1	K052164	Magnetom Systems with Software Syngo MR 2006A	Siemens Medical Solutions USA, Inc.	2005	—
0 (this device)	K080048	MSK Extreme MR Scanner, Model AA5000	Oni Medical Systems, Inc.	2008	—
+1	K103238	1.5T Optima MR430S	Ge Medical Systems, LLC	2011	2
+2	K123068	Optima MR 430S	Ge Medical Systems, LLC	2012	2

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2000	1	0
2001	1	0
2003	1	0
2005	4	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2012	1	0

FIG. 1 — Lineage of K080048, 1997–2012Source: 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.

2 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? (3)

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
*	K001773	Orthone Summary page 1 …mon Name: Magnetic Resonance Diagnostic Device Classification Magnetic Resonance Diagnostic Device Name: Predicate Device: OrthOne Extremity MRI Scanner (K00 1773) Philips Medical Systems Achieva 1.5T(K052013) MAGNETOM Systems with Software syngo MR 20…	Oni, Inc.	2000	1
*	K052013	Achieva 1.5T & Inera 1.5T Family Summary page 1 …on Magnetic Resonance Diagnostic Device Name: Predicate Device: OrthOne Extremity MRI Scanner (K00 1773) Philips Medical Systems Achieva 1.5T(K052013) MAGNETOM Systems with Software syngo MR 2006A (l.5T Symphony version) (K052164) Device…	Philips Medical Systems Nederland B.V.	2005	Class I
*	K052164	Magnetom Systems with Software Syngo MR 2006A Summary page 1 …Philips Medical Systems Achieva 1.5T(K052013) MAGNETOM Systems with Software syngo MR 2006A (l.5T Symphony version) (K052164) Device The MSK ExtreMeTM MR Scanner utilizes a Description: superconducting magnet to acquire 2D single-sli…	Siemens Medical Solutions USA, Inc.	2005	—

Also cleared against K001773: 1 other device →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K103238	1.5T Optima MR430S	Ge Medical Systems, LLC	2011	1

Has anything in its family been recalled? (2 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 9, 2016	Class II	Z-1927-2016	Nonconforming Material/Component	The gas venting may not occur properly. A site reported a magnet quenching with subsequent venting of the cryogen gas into the magnet room. Cryogen gas that vents into the magnet room could cause critical deprivation of oxygen to users…
Mar 28, 2013	Class II	Z-1211-2013	Process control	Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard.
Aug 29, 2011	Not classified	Z-0107-2012	Nonconforming Material/Component	GE Healthcare has recently become aware that an exposed high voltage gradient wire internal to the MSK 1.5T Extreme system equipment may cause electrical shock, which may impact service personnel safety. This issue does not impact patient…

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.

K052013Achieva 1.5T & Inera 1.5T FamilyPhilips Medical Systems Nederland B.V. · 2005 · Direct predicate · ◆ in the 2005 ancestors bar of FIG. 13 Class I recalls
K043147Achieva FamilyPhilips Medical Systems North America Co. · 2005 · 2 generations back · ◆ in the 2005 ancestors bar of FIG. 13 Class I recalls

What does this lineage say?

The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
10 of the 12 ancestors have a recall of any class; 2 have a Class I recall.
Of its descendants, K103238 (Ge Medical Systems, LLC, 2011) has gone furthest, with 1 descendant of its own.
1 other device also cites its predicate K001773.

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. 2008, 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?

The ONI MSK ExtremeTM MR Scanner is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee, ankle, foot, elbow, forearm, wrist, and hand. The device produces transverse, sagittal, coronal, and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. If interpreted by a medical expert, these images can provide diagnostically useful information.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K080048 · printed Nov 4, 2026

Cite this page

510(k) Report. “K080048: MSK Extreme MR Scanner, Model AA5000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080048

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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