LiverMultiScan

GUDID B554LMS4000

LiverMultiScan (LMSv4) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times. LiverMultiScan (LMSv4) is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced. LiverMultiScan (LMSv4) provides a number of tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessment of selected regions includes the determination of triglyceride fat fraction in the liver (PDFF), T2* and iron-corrected T1 (cT1) measurements. T2* may optionally be computed using the DIXON or LMS MOST methodologies. These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis.

PERSPECTUM LTD

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Primary Device IDB554LMS4000
NIH Device Record Key4f2c814a-0044-4ca0-9742-d02a40ef4c3a
Commercial Distribution StatusIn Commercial Distribution
Brand NameLiverMultiScan
Version Model Number4.0.0
Company DUNS218593632
Company NamePERSPECTUM LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4401865655343
Emailinfo@perspectum.com
Phone+4401865655343
Emailinfo@perspectum.com
Phone+4401865655343
Emailinfo@perspectum.com
Phone+4401865655343
Emailinfo@perspectum.com
Phone+4401865655343
Emailinfo@perspectum.com
Phone+4401865655343
Emailinfo@perspectum.com
Phone+4401865655343
Emailinfo@perspectum.com
Phone+4401865655343
Emailinfo@perspectum.com
Phone+4401865655343
Emailinfo@perspectum.com
Phone+4401865655343
Emailinfo@perspectum.com
Phone+4401865655343
Emailinfo@perspectum.com
Phone+4401865655343
Emailinfo@perspectum.com
Phone+4401865655343
Emailinfo@perspectum.com
Phone+4401865655343
Emailinfo@perspectum.com
Phone+4401865655343
Emailinfo@perspectum.com
Phone+4401865655343
Emailinfo@perspectum.com
Phone+4401865655343
Emailinfo@perspectum.com
Phone+4401865655343
Emailinfo@perspectum.com
Phone+4401865655343
Emailinfo@perspectum.com
Phone+4401865655343
Emailinfo@perspectum.com
Phone+4401865655343
Emailinfo@perspectum.com
Phone+4401865655343
Emailinfo@perspectum.com
Phone+4401865655343
Emailinfo@perspectum.com
Phone+4401865655343
Emailinfo@perspectum.com
Phone+4401865655343
Emailinfo@perspectum.com
Phone+4401865655343
Emailinfo@perspectum.com
Phone+4401865655343
Emailinfo@perspectum.com
Phone+4401865655343
Emailinfo@perspectum.com
Phone+4401865655343
Emailinfo@perspectum.com
Phone+4401865655343
Emailinfo@perspectum.com
Phone+4401865655343
Emailinfo@perspectum.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB554LMS4000 [Primary]

FDA Product Code

LNHSystem, Nuclear Magnetic Resonance Imaging

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-22
Device Publish Date2022-09-14

On-Brand Devices [LiverMultiScan]

B554LMS5000LiverMultiScan v5 (LMSv5) is indicated for use as a magnetic resonance diagnostic device softwar
B554LMS4000LiverMultiScan (LMSv4) is indicated for use as a magnetic resonance diagnostic device software a
B554LMS3500LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic device software a

Trademark Results [LiverMultiScan]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LIVERMULTISCAN
LIVERMULTISCAN
88601547 not registered Live/Pending
Perspectum Diagnostics Ltd
2019-09-02

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