510(k) · Cleared

Recalled · Class II · 2021

Orthone

K001773510(k) AbbreviatedCleared Aug 18, 200067-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

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

Cleared on Aug 18, 2000 after a 67-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 24 later devices descend from it. It has been recalled once.

Decided: Aug 18, 2000
Review: 67 days
Class: Class II
Product code: LNH
Recalls: 1
Predicates: 0

24 later devices descend from it, 2 citing it directly.

This deviceK001773 OrthoneOni, Inc. · 2000
Descendant · cites it directly · 20 of its ownK120701 M2 Wrist Mri SystemAspect Imaging, Ltd. · 2013
Descendant · 2 generations on · 19 of its ownK130692 M2 Wrist 2 Mri SystemAspect Imaging, Ltd. · 2014
Descendant · 3 generations on · 18 of its ownK160185 Wrist 3Aspect Imaging, Ltd. · 2016
Descendant · 4 generations on · 17 of its ownK170978 Embrace Neonatal MRI SystemAspect Imaging, Ltd. · 2017
Descendant · 5 generations on · 13 of its ownK192002 Lucy Point-of-Care Magnetic Resonance Imaging DeviceHyperfine Research, Inc. · 2020

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2008high 4 (2026) · low 0 (2009)2026

Most influential descendants

Showing 5 of 24 · See all

K120701M2 Wrist Mri SystemAspect Imaging, Ltd. · 2013 · cites it directly20descendants
K130692M2 Wrist 2 Mri SystemAspect Imaging, Ltd. · 2014 · 2 generations on19descendants
K160185Wrist 3Aspect Imaging, Ltd. · 2016 · 3 generations on18descendants
K170978Embrace Neonatal MRI SystemAspect Imaging, Ltd. · 2017 · 4 generations on17descendants
K192002Lucy Point-of-Care Magnetic Resonance Imaging DeviceHyperfine Research, Inc. · 2020 · 5 generations on13descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K001773	Orthone	Oni, Inc.	2000	—
+1	K120701	M2 Wrist Mri System	Aspect Imaging, Ltd.	2013	—
+2	K130692	M2 Wrist 2 Mri System	Aspect Imaging, Ltd.	2014	—
+3	K160185	Wrist 3	Aspect Imaging, Ltd.	2016	—
+4	K170978	Embrace Neonatal MRI System	Aspect Imaging, Ltd.	2017	—
+5	K192002	Lucy Point-of-Care Magnetic Resonance Imaging Device	Hyperfine Research, Inc.	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2011	1	0
2012	1	0
2013	1	0
2014	1	0
2016	1	0
2017	1	0
2020	2	0
2021	1	0
2022	2	0
2023	2	0
2024	3	0
2025	3	0
2026	4	0

FIG. 1 — Lineage of K001773, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (24)

See all 24

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

Number	Device	Applicant	Decided	Descendants
K120701	M2 Wrist Mri System	Aspect Imaging, Ltd.	2013	20
K080048	MSK Extreme MR Scanner, Model AA5000	Oni Medical Systems, Inc.	2008	2

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 23, 2021	Class II	Z-0621-2022	Process control	The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K120701 (Aspect Imaging, Ltd., 2013) has gone furthest, with 20 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	—

https://510kreport.com/device/K001773 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001773: Orthone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001773

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026