LiverMultiScan

Primary DI
B554LMS2000
Brand
LiverMultiScan
Company
PERSPECTUM LTD
Model
2.0
Device description
LiverMultiScan is a standalone software device. The purpose of the LiverMultiScan device is to assist the trained operator with the evaluation of information from Magnetic Resonance (MR) images from a single time-point (patient visit). A trained operator places circular regions of interest drawn upon previously acquired MR images, from which a summary report is generated. The summary report is sent to an interpreting clinician. LiverMultiScan does not replace the usual procedures for assessment of the liver by an interpreting clinician, providing many opportunities for competent human intervention in the interpretation of images and information displayed. 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 metrics. The purpose of LiverMultiScan metrics are to provide imaging information to assist in characterising tissue in the liver, which is additional to existing methods for obtaining information relating to the liver. LiverMultiScan metrics do not replace any existing diagnostic source of information, but can be used to identify patients who may benefit most from further evaluation, including biopsy. Information gathered through existing diagnostic tests and clinical evaluation of the patient, as well as information obtained from LiverMultiScan metrics, may contribute to a diagnostic decision.
Published
2018-01-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LNHSystem, Nuclear Magnetic Resonance Imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172685000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172685000LiverMultiScanPerspectum Diagnostics, Ltd.2017-11-21LNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B554LMS2000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
MRI system application softwareAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a magnetic resonance imaging (MRI) system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4401865655343info@perspectum-diagnostics.co
+4401865655343info@perspectum-diagnostics.com

Regulatory Flags#

DUNS number
218593632
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B554CSMD1200CoverScan1.2.02025-02-03
B554CSMD1100CoverScan1.1.02024-11-01
B554LMS5100LiverMultiScan5.1.02024-11-01
B554VSMD1000VitruvianScan1.02024-11-01
B554MRCP2000MRCP+2.0.02024-03-28
B554CSMD1000CoverScan1.0.02022-09-14
B554LMS3500LiverMultiScan3.5.02022-09-14
B554LMS4000LiverMultiScan4.0.02022-09-14
B554LMS5000LiverMultiScan5.0.02022-09-14
B554HEPATICA100Hepatica1.0.02021-02-12
B554LMS3400LiverMultiScan3.4.02020-11-03
B554LMS3300LiverMultiScan3.3.02020-03-20
B554LMS3200LiverMultiScan3.2.02020-01-13
B554LMS3100LiverMultiScan3.1.02019-09-17
B554LMS2100LiverMultiScan2.12018-07-04
B554MRCP1000MRCP+1.02019-02-04

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