FDA.reportPublic FDA data

MRCP+

Primary DI
B554MRCP2000
Brand
MRCP+
Company
PERSPECTUM LTD
Model
2.0.0
Device description
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.
Published
2024-03-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B554MRCP2000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+004401865655327Support@perspectum.com

Regulatory Flags#

DUNS number
218593632
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B554CSMD1200CoverScan1.2.02025-02-03
B554CSMD1100CoverScan1.1.02024-11-01
B554LMS5100LiverMultiScan5.1.02024-11-01
B554VSMD1000VitruvianScan1.02024-11-01
B554CSMD1000CoverScan1.0.02022-09-14
B554LMS3500LiverMultiScan3.5.02022-09-14
B554LMS4000LiverMultiScan4.0.02022-09-14
B554LMS5000LiverMultiScan5.0.02022-09-14
B554HEPATICA100Hepatica1.0.02021-02-12
B554LMS3400LiverMultiScan3.4.02020-11-03
B554LMS3300LiverMultiScan3.3.02020-03-20
B554LMS3200LiverMultiScan3.2.02020-01-13
B554LMS3100LiverMultiScan3.1.02019-09-17
B554LMS2100LiverMultiScan2.12018-07-04
B554MRCP1000MRCP+1.02019-02-04
B554LMS2000LiverMultiScan2.02018-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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