AccessGUDID - DEVICE: LiverMultiScan (B554LMS3100)

GUDID

Device Identifier (DI) Information

Brand Name: LiverMultiScan
Version or Model: 3.1.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PERSPECTUM LTD

Primary DI Number: B554LMS3100
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 218593632 *Terms of Use

Device Description: 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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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):	No
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: 5fa2b394-f082-4540-a45f-39bb3c9231a6
Public Version Date: December 04, 2023
Public Version Number: 4
DI Record Publish Date: September 17, 2019