CoverScan

GUDID B554CSMD1000

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.

PERSPECTUM LTD

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• Primary Device ID: B554CSMD1000
• NIH Device Record Key: fdea45c2-e40d-45a7-9a9e-04ca27662c1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoverScan
• Version Model Number: 1.0.0
• 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	B554CSMD1000 [Primary]

FDA Product Code

• LLZ: System, Image Processing, Radiological

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

Devices Manufactured by PERSPECTUM LTD

• B554MRCP2000 - MRCP+: 2024-04-05 MRCP+ v2 is a standalone software medical device. The purpose of the MRCP+ v2 device is to assist a trained operator with the qu
• B554CSMD1000 - CoverScan: 2022-09-22CoverScan 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.
• B554CSMD1000 - CoverScan: 2022-09-22 CoverScan is a medical image management and processing software package that allows the display, analysis and post-processing of
• B554LMS3500 - LiverMultiScan: 2022-09-22 LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive live
• B554LMS4000 - LiverMultiScan: 2022-09-22 LiverMultiScan (LMSv4) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive live
• B554LMS5000 - LiverMultiScan: 2022-09-22 LiverMultiScan v5 (LMSv5) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive l