510(k) · Cleared

Cleared

MOBINEURO Alita Intraoperative MRI System

K223875510(k) TraditionalCleared Mar 20, 202387-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

Sino Canada Health Engineering Research Institute (Hefei) · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Mar 20, 2023 after an 87-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided: Mar 20, 2023
Review: 87 days
Class: Class II
Product code: LNH
Recalls: None
Predicates: 0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K223875Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

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.

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. 2023, 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 MOBINEURO Alita Intraoperative MRI System is indicated for use for the head and whole body. The MOBINEURO Alita Intraoperative MRI System is intended for use as a diagnostic patient imaging device. This device produces tomographic cross-sectional images that: 1. Correspond to the distribution of protons exhibiting MR characteristics; 2. Depend on NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1) and spin-spin relaxation…

Read the full statement (142 words)

The MOBINEURO Alita Intraoperative MRI System is indicated for use for the head and whole body.

The MOBINEURO Alita Intraoperative MRI System is intended for use as a diagnostic patient imaging device. This device produces tomographic cross-sectional images that:

1. Correspond to the distribution of protons exhibiting MR characteristics;

2. Depend on NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1) and spin-spin relaxation time (T2); and

3. Display the soft tissue structure of the body.

When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The MOBINEURO Alita Intraoperative MRI System will also be used during intraoperative procedures when performed in an intraoperative MRI suite with MR compatible devices such as anesthesia and patient monitoring equipment.

The MOBINEURO Alita Intraoperative MRI System will also be used in a multi-room suite.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K223875 · printed Nov 5, 2026

Cite this page

510(k) Report. “K223875: MOBINEURO Alita Intraoperative MRI System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223875

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026