510(k) · Cleared

Cleared

Indomitable Magnetic Resonance Imaging Scanner Accessory

K061930510(k) SpecialCleared Jul 28, 200621-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

Fonar Corp. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Jul 28, 2006 as substantially equivalent to K002490 (Fonar Corp., 2000) after a 21-day review. Its family tree reaches back 1 generation to 2000.

Decided: Jul 28, 2006
Review: 21 days
Class: Class II
Product code: LNH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K002490 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK002490 Indomitable Magnetic Resonance Imaging ScannerFonar Corp. · 2000
This deviceK061930 Indomitable Magnetic Resonance Imaging Scanner AccessoryFonar Corp. · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K002490	Indomitable Magnetic Resonance Imaging Scanner	Fonar Corp.	2000	—
0 (this device)	K061930	Indomitable Magnetic Resonance Imaging Scanner Accessory	Fonar Corp.	2006	—

FIG. 1 — Lineage of K061930, 2000–2006Source: 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
*	K002490	Indomitable Magnetic Resonance Imaging Scanner Summary page 1 …corresponding increase in the maximum slew rate for the gradient waveforms. All other subsystems remain essentially unchanged from their previously approved (K002490) state. Device Modifications This modified gradient subsystem follows the same basic design principles as our previously…	Fonar Corp.	2000	—

What descends from it?

No later submission names this one as a predicate yet.

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no 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?

The Indomitable Magnetic Resonance Imaging System is indicated for use in producing images of multiple planes in the head and body. These images correspond to the distribution of hydrogen nuclei exhibiting nuclear magnetic resonance (NMR) and depend for their contrast upon NMR parameters [hydrogen nuclei concentration and flow velocity, Ti (spin-lattice relaxation time) and T2 (spin-spin relaxation time)]. As a result of the acquisition and processing of…

Read the full statement (212 words)

WARNING: This device is limited by U.S. Federal law to investigational use for indications not in the indications statement.

Under the requirements of the law, the non-indicated applications can be used only under an Institutional Review Board approved protocol for a non-significant risk device or an Investigational Device Exemption application approved by the FDA for a significant risk device. The procedures to be followed, under the sponsorship of FONAR Corporation, are determined by the current guidelines established by the FDA, which should provide the IRB with sufficient guidance to determine the level of risk for a MRI device.

WARNING: U.S. Federal law restricts the sale, distribution and use of this device by or on the order of a physician.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061930 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061930: Indomitable Magnetic Resonance Imaging Scanner Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061930

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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