Hepatica

GUDID B554HEPATICA100

Hepatica (Hepatica v1) is a post-processing medical device software that presents quantified metrics which may contribute to the assessment of a patient’s liver health.Hepatica (Hepatica v1) uses image visualisation and analysis tools to process DICOM 3.0 compliant magnetic resonance image datasets to produce semi-automatic segmented 3D models of the liver based on the work of Couinaud and the Brisbane 2000 terminology. For each identified Couinaud segment, volumetric data is determined and reported. Hepatica (Hepatica v1) may also report iron corrected-T1 (cT1) and PDFF calculated using the IDEAL methodfrom multi-slice acquisitions, on a per segment basis, over the whole liver. Both metrics present numerical values of different fundamental liver tissue characteristics that can be used as measures of liver tissue health.Hepatica (Hepatica v1) provides trained clinicians with additional information to evaluate the volume and health of a patient’s liver on a segmental basis. It is not intended to replace the established procedures for the assessment of a patient’s liver health. However, information gathered through existing diagnostic tests, clinical evaluation of the patient, as well Hepatica(Hepatica v1), may support surgical decision making.

PERSPECTUM DIAGNOSTICS LTD

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• Primary Device ID: B554HEPATICA100
• NIH Device Record Key: e7965190-e637-41a9-9f8d-ca9ebd830430
• Commercial Distribution Discontinuation: 2025-01-12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hepatica
• Version Model Number: 1.0.0
• Company DUNS: 218593632
• Company Name: PERSPECTUM DIAGNOSTICS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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

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• Phone: +4401865655343
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• Phone: +4401865655343
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• Phone: +4401865655343
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• Phone: +4401865655343
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• Phone: +4401865655343
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• Phone: +4401865655343
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• Phone: +4401865655343
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• Phone: +4401865655343
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• Phone: +4401865655343
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• Phone: +4401865655343
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• Phone: +4401865655343
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• Phone: +4401865655343
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• Phone: +4401865655343
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• Phone: +4401865655343
• Email: info@perspectum.com
• Phone: +4401865655343
• Email: info@perspectum.com
• Phone: +4401865655343
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• Phone: +4401865655343
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Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B554HEPATICA100 [Primary]

FDA Product Code

• LNH: System, Nuclear Magnetic Resonance Imaging

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: 2021-02-22
• Device Publish Date: 2021-02-12

Devices Manufactured by PERSPECTUM DIAGNOSTICS LTD

• B554HEPATICA100 - Hepatica: 2021-02-22Hepatica (Hepatica v1) is a post-processing medical device software that presents quantified metrics which may contribute to the assessment of a patient’s liver health.Hepatica (Hepatica v1) uses image visualisation and analysis tools to process DICOM 3.0 compliant magnetic resonance image datasets to produce semi-automatic segmented 3D models of the liver based on the work of Couinaud and the Brisbane 2000 terminology. For each identified Couinaud segment, volumetric data is determined and reported. Hepatica (Hepatica v1) may also report iron corrected-T1 (cT1) and PDFF calculated using the IDEAL methodfrom multi-slice acquisitions, on a per segment basis, over the whole liver. Both metrics present numerical values of different fundamental liver tissue characteristics that can be used as measures of liver tissue health.Hepatica (Hepatica v1) provides trained clinicians with additional information to evaluate the volume and health of a patient’s liver on a segmental basis. It is not intended to replace the established procedures for the assessment of a patient’s liver health. However, information gathered through existing diagnostic tests, clinical evaluation of the patient, as well Hepatica(Hepatica v1), may support surgical decision making.
• B554HEPATICA100 - Hepatica: 2021-02-22 Hepatica (Hepatica v1) is a post-processing medical device software that presents quantified metrics which may contribute to the
• B554LMS3400 - LiverMultiScan: 2021-02-15 LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive live
• B554LMS3300 - LiverMultiScan: 2020-03-30 LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive live
• B554LMS3200 - LiverMultiScan: 2020-01-21 LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive live
• B554LMS3100 - LiverMultiScan: 2019-10-07 LiverMultiScan (LMSv3) is a standalone software device. The purpose of the LiverMultiScan (LMSv3) device is to assist the traine
• B554LMS2100 - LiverMultiScan: 2019-10-07 LiverMultiScan is a standalone software device. The purpose of the LiverMultiScan device is to assist the trained operator with
• B554MRCP1000 - MRCP+: 2019-10-07 MRCP+v1 is indicated for use as a software-based image processing system for non-invasive, quantitative assessment of biliary sy
• B554LMS2000 - LiverMultiScan: 2018-07-06 LiverMultiScan is a standalone software device. The purpose of the LiverMultiScan device is to assist the trained operator with