LiverMultiScan

LiverMultiScan (LMSv3) is a standalone software device. The purpose of the LiverMultiScan (LMSv3) device is to assist the trained operator with the evaluation of information from Magnetic…

Registry build 21.09.26

LiverMultiScan (LMSv3) is a standalone software device. The purpose of the LiverMultiScan (LMSv3) device is to assist the trained operator with the evaluation of information from Magnetic Resonance (MR) images from a single time-point (patient visit). The LiverMultiScan (LMSv3) is a post-processing software device, a trained operator uses tools such as automatic liver segmentation and region of interest placement upon previously acquired MR images, from which a summary report is generated. The summary report is then sent to an interpreting clinician. The interpreting clinician needs to take into consideration the device’s limitations and accuracy during clinical interpretation. LiverMultiScan (LMSv3) is not intended to replace the established procedures for the assessment of a patients liver health by an interpreting clinician, providing many opportunities for competent human intervention in the interpretation of images and information displayed. The device is intended to be used by a trained operator to generate metrics for subsequent interpretation by a clinician. The metrics are intended to be used as an additional diagnostic input to provide information to clinicians as part of a wider diagnostic process. It is expected that in the normal course of liver disease diagnosis, patients will present with clinical symptoms or risk factors which may indicate liver disease. Liver function tests, blood tests, ultrasound scanning as well as liver biopsy are all expected to be used at the discretion of a qualified clinician in addition to information obtained from the use of LiverMultiScan (LMSv3) metrics. The purpose of a LiverMultiScan (LMSv3) metrics is to provide imaging information to assist in characterizing tissue in the liver, which are additional to existing methods for obtaining information relating to the liver. LiverMultiScan (LMSv3) metrics are not intended to replace any existing diagnostic source of information, but can be used to identify patients who

12manufacturers in China registered for this device type
10catalogue numbers in this listing
5510(k) clearances naming this product 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 LiverMultiScan
Listed by Perspectum Ltd., United Kingdom
FDA product code LNH
Device type System, Nuclear Magnetic Resonance Imaging
Device class Class 2
Regulation 21 CFR 892.1000
Establishment Manufacturer
510(k) K172685
Record published 2018-07-04
Record revised 2023-12-04 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for LiverMultiScan
Catalogue number Size Status
2.1 In distribution
2.0 In distribution
3.1.0 In distribution
5.1.0 In distribution
4.0.0 In distribution
3.5.0 In distribution
3.3.0 In distribution
3.2.0 In distribution
3.4.0 In distribution
5.0.0 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
K253413 2026-03-09
K241925 2024-10-02
K213960 2022-09-06
K203280 2021-01-12
K202170 2020-10-02

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer