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

• 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

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• 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.
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