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Mrcp+

FDA UDI

Class II (US FDA UDI)

by Perspectum

Identity

Trade Name
MRCP+ FDA UDI
Generic Name
Radiology DICOM image processing application software FDA UDI
Device Name
MRCP+v1 is indicated for use as a software-based image processing system for non-invasive, quantitative assessment of biliary system structures by facilitating the generation, visualisation and review of three-dimensional quantitative biliary system models and anatomical image data. MRCP+v1 calculates quantitative three-dimensional biliary system models that enable measurement of bile duct widths and automatic detection of regions of variation (ROV) of tubular structures. MRCP+v1 includes tools for interactive segmentation and labelling of the biliary system and tubular structures. MRCP+v1 allows for regional volumetric analysis of segmented tree-like, tubular structures and the gallbladder. Combining image viewing, processing and reporting tools, the metrics provided is designed to support physicians in the visualization, evaluation and reporting of hepatobiliary structures. These models and the physical parameters derived from the models, when interpreted by a trained physician, yield information that may assist in biliary system assessment. MRCP+v1 is designed to utilize DICOM compliant MRCP datasets, acquired on supported MR scanners using supported MRCP acquisition protocols. MRCP+v1 is suitable for all patients not contra-indicated for MRI. FDA UDI
Model / Reference
1.0 FDA UDI
Description
MRCP+v1 is indicated for use as a software-based image processing system for non-invasive, quantitative assessment of biliary system structures by facilitating the generation, visualisation and review of three-dimensional quantitative biliary system models and anatomical image data. MRCP+v1 calculates quantitative three-dimensional biliary system models that enable measurement of bile duct widths and automatic detection of regions of variation (ROV) of tubular structures. MRCP+v1 includes tools for interactive segmentation and labelling of the biliary system and tubular structures. MRCP+v1 allows for regional volumetric analysis of segmented tree-like, tubular structures and the gallbladder. Combining image viewing, processing and reporting tools, the metrics provided is designed to support physicians in the visualization, evaluation and reporting of hepatobiliary structures. These models and the physical parameters derived from the models, when interpreted by a trained physician, yield information that may assist in biliary system assessment. MRCP+v1 is designed to utilize DICOM compliant MRCP datasets, acquired on supported MR scanners using supported MRCP acquisition protocols. MRCP+v1 is suitable for all patients not contra-indicated for MRI. FDA UDI

Identifiers

Primary DI / UDI-DI
B554MRCP1000 FDA UDI
FDA Product Code
LNH FDA UDI
GMDN Term
Radiology DICOM image processing application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1000 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Radiology DICOM image processing application software

Mrcp+ by Perspectum — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiology DICOM image processing application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Perspectum

Sources (1)

  • FDA UDI c841b43a-8830-48d6-b02b-9b6f78de2fca 34 fields · synced May 30, 2026