Who else makes this device?

Name: Neuro III-SV iMRI System
Brand: Neuro III-SV iMRI System

Neuro III-SV iMRI System · System, Nuclear Magnetic Resonance Imaging → Radiology

12manufacturers in China registered for this device type

2catalogue numbers in this listing

1510(k) clearance

7recalls on this code

Who Else Makes It

Concentrated in Shanghai (3), Beijing (2), Guangdong (2). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code LNH
Manufacturer	City	Province	Registered as	Device types
Shanghai Chenguang Medical Technologies Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	2
GE Healthcare (China) Co., Ltd.	Beijing	Beijing	Specification developer	22
Shanghai United Imaging Healthcare Co., Ltd.	Shanghai	Shanghai	Manufacturer	12
Siemens Shenzhen Magnetic Resonance Ltd.	Shenzhen	Guangdong	Contract manufacturer	8
GE Healthcare (Tianjin) Company Limited	Tianjin	Tianjin	Specification developer	5
GE Healthcare (China) Co., Ltd. – Tianjin	Tianjin	Tianjin	Specification developer	3
Shenzhen RF Tech Co., Ltd.	Shenzhen	Guangdong	Complaint-file establishment	2
Shanghai Chenshi Medical Instruments Co., Ltd.	Shanghai	Shanghai	Exporter	2
MRI Division, Beijing Wandong Medical Technology Co., Ltd.	Beijing	Beijing	Manufacturer	1
Jiangsu Magspin Instrument Co., Ltd.	Kunshan	Jiangsu	Manufacturer	1
Xingaoyi Medical Equipment Co., Ltd.	Yuyao	Zhejiang	Manufacturer	1
Sino Canada Health Engineering Research Institute (Hefei) Ltd. (Scheri)	Hefei	Anhui	Complaint-file establishment	1

Record

Regulatory record for Neuro III-SV iMRI System
Listed by	Imris Imaging, Inc., United States
FDA product code	LNH
Device type	System, Nuclear Magnetic Resonance Imaging
Device class	Class 2
Regulation	21 CFR 892.1000
Establishment	Specification developer, Complaint-file establishment, Manufacturer
510(k)	K083137
Record published	2016-09-22
Record revised	2025-04-08 (version 4)

Specifications

Specifications
MRI safety	MR Conditional
Prescription	Prescription only
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Neuro III-SV iMRI System
Catalogue number	Size	Status
Neuro III-SV iMRI System		In distribution
Neuro III-SV iMRI System		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Ingenia	Philips Medical Systems Nederland B.V.	72
System, Nuclear Magnetic Resonance Imaging	GE Medical Systems, L.L.C.	40
System, Nuclear Magnetic Resonance Imaging	Medtronic Navigation, Inc.	23
Uni-frame® Thermoplastic	Medtec LLC	19
Positioning Cushion	Medtec LLC	18
Posicast® Thermoplastic	Medtec LLC	18
System, Nuclear Magnetic Resonance Imaging	GE Healthcare (Tianjin) Company Limited	16
Invivo	Philips DS North America LLC	15
Type-S™ Thermoplastic	Medtec LLC	14
Aperto Lucent	Fujifilm Corporation	13
MRI Integral “T” with Check Valve for Medrad® Spectris MR Injector	Bayer Medical Care Inc.	11
PPG Finger Band	IVY Biomedical Systems, Inc.	11

Showing 12 of 478. All products under System, Nuclear Magnetic Resonance Imaging

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K252239	2025-08-06

Recalls Naming This Product

6 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Neuro III-SV iMRI System
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Imris Imaging, Inc.	510(k) number	2025-09-30	Class I	Under Investigation by firm	There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the
Imris Imaging, Inc.	510(k) number	2025-09-30	Class I	Under Investigation by firm	There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the
Imris Imaging, Inc.	510(k) number	2025-09-30	Class I	Under Investigation by firm	There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the
Imris Imaging, Inc.	510(k) number	2025-09-30	Class I	Under Investigation by firm	There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the
Imris Imaging, Inc.	510(k) number	2016-02-10	Class II	Device Design	Emergency helium venting lines (i.e. quench lines) may not have been properly installed.	35 USA, 14 OUS	2017-04-05
Innovative Magnetic Resonance Imaging Systems, Inc.	510(k) number	2012-10-19	Class II	Labeling design	IMRIS Inc. initiated a recall of their OR Tables ORT100 and ORT200. When proper procedure is not followed, the foot end of the IMRIS intra-operative OR table may be attracted to the MRI magnet as the magnet approaches the table. This poses	23	2012-12-11

Recalls

2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2019-11-26	Class II	Component design/selection	There is a potential hardware error for the iMRX System with a generator A100. A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be	6	2020-08-04
2018-04-04	Class II	Device Design	The DC power to the IFOSS collision detector control panel at your facility is being adversely affected by the magnetic field. Our investigation shows the magnetic field is causing the IFOSS control panel to malfunction.	10 units	2020-07-22

PMA Approvals

A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.

FDA premarket approvals naming this product code
PMA number	Decision	Trade name	Approved to
P860010	1988-06-12	INSTRUMENTARIUM ULF MR IMAGING SYSTEM	Palomex Instrumentarium Corp.
P860062	1988-05-25	RESONEX RX4000{TM} MAGNETIC RESONANCE IMAGING SYST	Resonex, Inc.
P850043	1987-12-30	MAGNISCAN 5000 MRI SYSTEM	Thomson-Cgr Medical Corp.
P830074	1987-11-25	GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS	General Electric Co.
P840063	1987-08-11	GYROSCAN(TM)	Philips Medical Systems Technologies Ltd
P840007	1987-04-02	GYREX, MODELS S3500 & S5000	Elscint, Inc.
P830076	1986-10-08	FONAR NMR WHOLE BODY SCANNER BETA 3000	Fonar Corp.
P830052	1986-05-28	NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000	Philips Medical Systems (Cleveland), Inc.
P830051	1986-04-30	TESLACON(TM) NMR IMAGING SYSTEM	Technicare Corp.
P830053	1985-12-18	DIASONICS NMR IMAGING SYSTEM	Diasonics, Inc.
P830081	1985-06-06	MAGNETOM	Siemens Healthcare Limited

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Neuro III-SV iMRI System