AccessGUDID - DEVICE: LiverMultiScan (B554LMS4000)

GUDID

Device Identifier (DI) Information

Brand Name: LiverMultiScan
Version or Model: 4.0.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PERSPECTUM LTD

Primary DI Number: B554LMS4000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 218593632 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
57812	Radiology DICOM image processing application software	A software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LNH	System, Nuclear Magnetic Resonance Imaging

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4f2c814a-0044-4ca0-9742-d02a40ef4c3a
Public Version Date: December 04, 2023
Public Version Number: 2
DI Record Publish Date: September 14, 2022