FDA.reportPublic FDA data

CoverScan

Primary DI
B554CSMD1000
Brand
CoverScan
Company
PERSPECTUM LTD
Model
1.0.0
Device description
CoverScan is a medical image management and processing software package that allows the display, analysis and post-processing of DICOM compliant medical images and MR data.CoverScan provides both viewing and analysis capabilities to ascertain quantified metrics of multiple organs such as the heart, lungs, liver, spleen, pancreas and kidney.CoverScan provides measurements in different organs to be used for the assessment of longitudinal and transversal relaxation time and rate (T1, SR-T1, cT1, T2), fat content (proton density fat fraction or PDFF) and metrics of organ function (e.g., left ventricular ejection fraction and lung fractional area change on deep inspiration).These metrics derived from the images, when interpreted by a licensed physician, yield information that may assist in diagnosis, clinical management and monitoring of patients.CoverScan is not intended for asymptomatic screening. This device is intended for use with Siemens 1.5T MRI scanners.
Published
2022-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B554CSMD1000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA 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 manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
218593632
Device count
1

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
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
B554LMS2000LiverMultiScan2.02018-01-26

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Primary DI, Brand, Company table
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