MRCP+

GUDID B554MRCP2000

MRCP+ v2 is a standalone software medical device. The purpose of the MRCP+ v2 device is to assist a trained operator with the quantitative evaluation of biliary system structures acquired from magnetic resonance (MR) images from a single time-point (a patient visit). A Perspectum-trained operator loads previously acquired magnetic resonance cholangiopancreatography (MRCP) data as input into the MRCP+ v2 device. A structured summary report is generated as output by the device, which includes quantitative analysis results and geometric characteristics of the biliary system and pancreatic ducts. The MRCP+ v2 report is intended to facilitate reporting by a radiologist for subsequent interpretation and to aid diagnosis by a physician as part of a panel of testing, including conventional radiological tools.

PERSPECTUM LTD

Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software

• Primary Device ID: B554MRCP2000
• NIH Device Record Key: 3ff165e7-e561-472c-b2c9-6fc06d2d5cc2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MRCP+
• Version Model Number: 2.0.0
• Company DUNS: 218593632
• Company Name: PERSPECTUM 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

• Phone: +004401865655327
• Email: Support@perspectum.com
• Phone: +004401865655327
• Email: Support@perspectum.com
• Phone: +004401865655327
• Email: Support@perspectum.com
• Phone: +004401865655327
• Email: Support@perspectum.com
• Phone: +004401865655327
• Email: Support@perspectum.com
• Phone: +004401865655327
• Email: Support@perspectum.com
• Phone: +004401865655327
• Email: Support@perspectum.com
• Phone: +004401865655327
• Email: Support@perspectum.com
• Phone: +004401865655327
• Email: Support@perspectum.com
• Phone: +004401865655327
• Email: Support@perspectum.com
• Phone: +004401865655327
• Email: Support@perspectum.com
• Phone: +004401865655327
• Email: Support@perspectum.com
• Phone: +004401865655327
• Email: Support@perspectum.com
• Phone: +004401865655327
• Email: Support@perspectum.com
• Phone: +004401865655327
• Email: Support@perspectum.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B554MRCP2000 [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: 2024-04-05
• Device Publish Date: 2024-03-28

Devices Manufactured by PERSPECTUM LTD

• B554MRCP2000 - MRCP+: 2024-04-05MRCP+ v2 is a standalone software medical device. The purpose of the MRCP+ v2 device is to assist a trained operator with the quantitative evaluation of biliary system structures acquired from magnetic resonance (MR) images from a single time-point (a patient visit). A Perspectum-trained operator loads previously acquired magnetic resonance cholangiopancreatography (MRCP) data as input into the MRCP+ v2 device. A structured summary report is generated as output by the device, which includes quantitative analysis results and geometric characteristics of the biliary system and pancreatic ducts. The MRCP+ v2 report is intended to facilitate reporting by a radiologist for subsequent interpretation and to aid diagnosis by a physician as part of a panel of testing, including conventional radiological tools.
• 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: 2022-09-22 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