LiverMultiScan

GUDID B554LMS3500

LiverMultiScan (LMSv3) 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 (LMSv3) 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 (LMSv3) 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. PDFF may optionally be computed using the LMS IDEAL or three-point Dixon methodology. 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

Radiology DICOM image processing application software

• Primary Device ID: B554LMS3500
• NIH Device Record Key: 5e272a9a-6315-4490-9a78-8f253eedecfd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LiverMultiScan
• Version Model Number: 3.5.0
• Company DUNS: 218593632
• Company Name: PERSPECTUM LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4401865655343
• Email: info@perspectum.com
• Phone: +4401865655343
• Email: info@perspectum.com
• Phone: +4401865655343
• Email: info@perspectum.com
• Phone: +4401865655343
• Email: info@perspectum.com
• Phone: +4401865655343
• Email: info@perspectum.com
• Phone: +4401865655343
• Email: info@perspectum.com
• Phone: +4401865655343
• Email: info@perspectum.com
• Phone: +4401865655343
• Email: info@perspectum.com
• Phone: +4401865655343
• Email: info@perspectum.com
• Phone: +4401865655343
• Email: info@perspectum.com
• Phone: +4401865655343
• Email: info@perspectum.com
• Phone: +4401865655343
• Email: info@perspectum.com
• Phone: +4401865655343
• Email: info@perspectum.com
• Phone: +4401865655343
• Email: info@perspectum.com
• Phone: +4401865655343
• Email: info@perspectum.com
• Phone: +4401865655343
• Email: info@perspectum.com
• Phone: +4401865655343
• Email: info@perspectum.com
• Phone: +4401865655343
• Email: info@perspectum.com
• Phone: +4401865655343
• Email: info@perspectum.com
• Phone: +4401865655343
• Email: info@perspectum.com
• Phone: +4401865655343
• Email: info@perspectum.com
• Phone: +4401865655343
• Email: info@perspectum.com
• Phone: +4401865655343
• Email: info@perspectum.com
• Phone: +4401865655343
• Email: info@perspectum.com
• Phone: +4401865655343
• Email: info@perspectum.com
• Phone: +4401865655343
• Email: info@perspectum.com
• Phone: +4401865655343
• Email: info@perspectum.com
• Phone: +4401865655343
• Email: info@perspectum.com
• Phone: +4401865655343
• Email: info@perspectum.com
• Phone: +4401865655343
• Email: info@perspectum.com
• Phone: +4401865655343
• Email: info@perspectum.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B554LMS3500 [Primary]

FDA Product Code

• LNH: System, Nuclear Magnetic Resonance Imaging

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-22
• Device Publish Date: 2022-09-14

On-Brand Devices [LiverMultiScan]

• B554LMS5000: LiverMultiScan v5 (LMSv5) is indicated for use as a magnetic resonance diagnostic device softwar
• B554LMS4000: LiverMultiScan (LMSv4) is indicated for use as a magnetic resonance diagnostic device software a
• B554LMS3500: LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic device software a
• B554LMS5100: LiverMultiScan v5 (LMSv5) is indicated for use as a magnetic resonance diagnostic device softwar