MRCP+ version 2 (MRCP+ v2)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. Perspectum Keri Hildick Chief Strategy Officer Gemini One 5220 John Smith Drive Oxford, Oxfordshire OX4 2LL United Kingdom March 13, 2024 Re: K233930 Trade/Device Name: MRCP+ version 2 (MRCP+ v2) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: December 14, 2023 Received: March 1, 2024 Dear Keri Hildick: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Jessica Lamb Jessica Lamb. Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use Submission Number (if known) K233930 Device Name MRCP+ version 2 (MRCP+ v2) Indications for Use (Describe) MRCP+ v2 is indicated for use as a software-based image processing system for noninvasive, quantitative assessment of biliary system structures. MRCP+ v2 calculates quantitative three-dimensional biliary system models that enable the measurement of bile duct widths and quantification of strictures and dilatations. MRCP+ v2 includes tools for interactive segmentation and labelling of the biliary system, including the gallbladder. MRCP+ v2 provides metrics for interpretation by trained physicians to assist in the assessment of the biliary system. These metrics support physicians in the visualization, evaluation and reporting of hepatobiliary structures. MRCP+ v2 is designed to utilize DICOM-compliant MRCP datasets acquired on supported MR scanners using supported MRCP acquisition protocols. Type of Use (Select one or both, as applicable) ( Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Date Prepared: 12th March 2023 ### Submitter Details 1 Owner Address: Perspectum Ltd Gemini One, 5520 John Smith Drive, Oxford Business Park, Oxford, OX4 2LL Owner/Operator Number: Establishment Registration Number: Contact Person: 10056574 3014232555 Bhaskar Chikkanna bhaskar.chikkanna@perspectum.com +44 (0) 1865 655329 # 2 Subject and Predicate Device | | Subject Device | Predicate Device | |--------------------------------|-------------------------------------------|-------------------------------------------| | 510(k) number | K233930 | K183133 | | Legal Manufacturer | Perspectum Ltd. | Perspectum Ltd. | | Owner/Owner Operator<br>Number | 10056574 | 10056574 | | Device Name | MRCP+ version 2 (MRCP+ v2) | MRCP+ (MRCP+ v1) | | Proprietary/Common name | MRCP+ | MRCP+ | | Panel | Radiology | Radiology | | Regulation | 892.2050 | 892.2050 | | Risk Class | Class II | Class II | | Product Class code | LLZ | LLZ | | Classification | System, Image Processing,<br>Radiological | System, Image Processing,<br>Radiological | ### Subject Device Description 3 ### 3.1 General 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 maqnetic 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. Image /page/3/Picture/15 description: The image shows the logo for Perspectum. The word "Perspectum" is written in a bold, sans-serif font in blue. To the right of the word is a circular graphic divided into sections of different colors, including blue, green, and pink. Below the word "Perspectum" is the text "K233930". {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the word "Perspectum" in a bold, dark blue font. To the right of the word is a circular logo. The logo is divided into four sections, with the top three sections colored light blue, green, and pink, respectively, and the bottom section colored dark blue. MRCP+ v2 is designed to utilize Digital Imaging and Communications in Medicine (D/COM)-compliant MRCP datasets acquired on supported MR scanners to display the fluid-filled tubular structures in the abdomen, including intra- and extra-hepatic biliary tree, qallbladder, and pancreatic duct system. Analysis and evaluation tools in MRCP+ v2 include segmentation of structures utilizing user input of seeding points, interactive labelling of segmented areas, and quantitative measurement derived from segmentation results. MRCP+ v2 calculates quantitative three-dimensional biliary system models that enable measurement of bile duct widths and automatic detection of regions of variation in the width of tubular structures, including those quantified as strictures and dilations. MRCP+ v2 includes tools allowing for regional volumetric analysis of segmented tree-like, tubular structures and the gallbladder. Image /page/4/Picture/3 description: The image shows a 3D rendering of a network of vessels, likely blood vessels or ducts, with a color gradient indicating the diameter in millimeters. The color scale ranges from red to blue, with red representing smaller diameters (around 0 mm) and blue representing larger diameters (around 12 mm). The vessels are branching out from a central region, with the main trunk appearing in shades of green and yellow, indicating a diameter of approximately 5-8 mm. Figure 1: 3D image of the biliary tree constructed from MRCP+ and color coded according to duct widths (mm) The MRCP+ v2 report is intended to supplement conventional radiology reports. MRCP+ v2 does not replace the usual procedures for assessing the biliary system by a reviewing radiologist or interpreting physician, providing many opportunities for competent human intervention images and information. A radiologist or physician must also consider the device's limitations and accuracy when reviewing or interpreting MRCP+ v2 results and reports. Therefore, MRCP+ v2 presents a low level of concern with respect to patient safety since its metrics only augment the clinical information utilized by radiologists and physicians for the medical management of patients. ### 3.2 Indications for Use MRCP+ v2 is indicated for use as a software-based image processing system for noninvasive, quantitative assessment of biliary system structures. MRCP+ v2 calculates quantitative three-dimensional biliary system models that enable the measurement of bile duct widths and quantification of strictures and dilatations. MRCP+ v2 includes tools for interactive segmentation and labelling of the biliary system, including the gallbladder. MRCP+ v2 provides metrics for interpretation by trained physicians to assist in the assessment of the biliary system. These metrics support physicians in the visualization and reporting of hepatobiliary structures. MRCP+ v2 is designed to utilize DICOM-compliant MRCP datasets acguired on supported MR scanners using supported MRCP acquisition protocols. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for Perspectum. The word "Perspectum" is written in a dark blue, sans-serif font. To the right of the word is a circular graphic that is divided into four sections. The top three sections are colored light blue, green, and pink, while the bottom section is dark blue. ### 3.3 Intended Patient Population General population - MRCP+ v2 has no demographic or population restrictions. MRCP+ v2 analyzes hepatobiliary structures from appropriately acquired MR datasets. MRCP+ v2 is not intended to be used for any specific disease or condition. The information provided by the MRCP+ v2 report may offer valuable additional input to support a diagnostic decision when interpreted by a trained physician. ### 3.4 Contraindications MRCP+ v2 is suitable for all patients not contra-indicated for MRI. MRCP+ v2 has the following contra-indications. - . MRCP+ v2 reports should not be used as the sole basis for forming a diagnosis – to do so would constitute a misuse of the device. - . MRCP+ v2 reports should not be used as a control mechanism for biopsy guidance – to do so would constitute a misuse of the device. - . MRCP+ v2 reports should not be used as a direct control mechanism for the delivery of treatment – to do so would constitute a misuse of the device. - . MRCP+ v2 reports should not be used as the sole basis for evaluating the response to treatment – to do so would constitute a misuse of the device. ### 3.5 Intended Conditions MRCP+ v2 is not intended to be used for the diagnosis, treatment or monitoring of any specific diseases or conditions. MRCP+ v2 does not have any demographic restrictions. MRCP+ v2 is indicated for use in any patient where MRI is not contraindicated. MRCP+ v2 does not require the use of contrasting agent. ### 3.6 Biological properties N/A - MRCP+ v2 is a post-processing standalone software device. MRCP+ v2 does not have any chemical, physical or biological properties and does not incorporate substances which are considered medicinal products or human blood derivatives. MRCP+ v2 does not contain tissues, cells, or substances of animal origin. ### 3.7 Materials N/A - MRCP+ v2 is a post-processing standalone software device. MRCP+ v2 does not consist of any physical materials. Thus toxicity, flammability, phthalates, contamination because of the inqress or egress of substances are not applicable to this device. ### 3.8 Substances N/A - MRCP+ v2 is a post-processing standalone software device. Risks posed by substances or particles, including wear debris, degradation products and processing residues, are not applicable to this device. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the word "Perspectum" in a bold, dark blue font. To the right of the word is a circular logo. The logo is divided into four colored sections: light blue, green, pink, and dark blue. The dark blue section is further divided by a white line. ## 3.9 Lifetime of the device N/A - MRCP+ v2 is a post-processing standalone software device. The lifetime of the device is indefinite until support for MRCP+ v2 is withdrawn by the manufacturer. The performance characteristics of MRCP+ v2 do not degrade over time. MRCP+ v2 lifetime is dependent on its continued use in accordance with the minimum technical requirements for the operating system, hardware, and browsers. ### 3.10 Packaging and transport N/A — MRCP+ v2 is a post-processing standalone software device. The performance characteristics of MRCP+ v2 will not be adversely affected during transport and storage. MRCP+ v2 is operated using general-purpose computing hardware that meets the minimum technical requirements for its use. ### 3.11 Sterility N/A - MRCP+ v2 is a post-processing standalone software device. It is non-contact, noninvasive and non-sterile. ### 3.12 Radiation and energy supply N/A - MRCP+ v2 is a post-processing software device. It does not emit any kind of radiation. MRCP+ v2 does not supply patients with a source of energy or any other substances. ## 3.13 Power supply N/A — MRCP+ v2 is a post-processing software device. The safety of patients does not depend on internal and/or external power supply. MRCP+ v2 does not supply patients with any form of power supply. ## 3.14 Mechanical properties N/A — MRCP+ v2 is a post-processing standalone software device. MRCP+ v2 does not emit noise, generate vibrations, or include mechanically moving parts. Compliance with the Machinery Directive (2006/42/EC) is not required. ### 3.15 Personal protective equipment N/A - MRCP+ v2 is a post-processing standalone software device. Thus, MRCP+ v2 is not intended to be used as a personal protective equipment. Compliance with the Personal Protective Equipment Directive (2016/425) is not required. ### 3.16 Electronic instructions for use The instructions for use accompanying MRCP+ v2 comply with the Electronic Instructions for Use of Medical Devices Regulation (207/2012). ### Subject and Predicate Comparison ব Table 1 provides a comparison of characteristics between the subject device (MRCP+ v2) and the predicate device (MRCP+ v1) to demonstrate substantial equivalence. Differences between the devices are highlighted. ### 4.1 Subject Device and Predicate Comparison The following characteristics were compared between the subject device and the predicate device to demonstrate substantial equivalence. Differences between the devices are highlighted. {7}------------------------------------------------ Table 1. Comparison between the predicate and subject devices. | Characteristic | MRCP+ v2 (subject device) | MRCP+ v1 (predicate device) | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for<br>Use | MRCP+ v2 is indicated for use as a software-<br>based image processing system for<br>noninvasive, quantitative assessment of biliary<br>system structures.<br><br>MRCP+ v2 calculates quantitative three-<br>dimensional biliary system models that enable<br>the measurement of bile duct widths and<br>quantification of strictures and dilatations.<br>MRCP+ v2 includes tools for interactive<br>segmentation and labelling of the biliary<br>system including the gallbladder.<br><br>MRCP+ v2 provides metrics for interpretation<br>by trained physicians to assist in the<br>assessment of the biliary system. Thesemetrics support physicians in the<br>visualization, evaluation and reporting of<br>hepatobiliary structures.<br><br>MRCP+ v2 is designed to utilize DICOM<br>compliant MRCP datasets, acquired on<br>supported MR scanners using supported<br>MRCP acquisition protocols. | MRCP+ v1 is indicated for use as a software-<br>based image processing system for non-<br>invasive, quantitative assessment of biliary<br>system structures by facilitating the<br>generation, visualisation and review of three-<br>dimensional quantitative biliary system<br>models and anatomical image data.<br><br>MRCP+ v1 calculates quantitative three-<br>dimensional biliary system models that enable<br>measurement of bile duct widths and<br>automatic detection of regions of variation<br>(ROV) of tubular structures. MRCP+ v1<br>includes tools for interactive segmentation<br>and labelling of the biliary system and tubular<br>structures. MRCP+v1 allows for regional<br>volumetric analysis of segmented tree-like,<br>tubular structures and the gallbladder.<br><br>Combining image viewing, processing and<br>reporting tools, the metrics provided is<br>designed to support physicians in the<br>visualization, evaluation and reporting of<br>hepatobiliary structures. These models and<br>the physical parameters derived from the<br>models, when interpreted by a trained<br>physician, yield information that may assist in<br>biliary system assessment.<br><br>MRCP+ v1 is designed to utilize DICOM<br>compliant MRCP datasets, acquired on<br>supported MR scanners using supported<br>MRCP acquisition protocols.<br><br>MRCP+ v1 is suitable for all patients not<br>contra-indicated for MRI. | | Intended<br>Conditions | MRCP+ v2 is not intended to be used for the<br>diagnosis, treatment or monitoring of any<br>specific diseases or conditions.<br><br>MRCP+ v2 does not have any demographic<br>restrictions.<br><br>MRCP+ v2 is indicated for use in any patient<br>where MRI is not contraindicated.<br><br>MRCP+ v2 does not require the use of<br>contrasting agent. | MRCP+ v1 is not intended to be used for the<br>diagnosis, treatment or monitoring of any<br>specific diseases or conditions. | | Contraindications | Same as predicate | MRCP+ v1 is suitable for all patients not contra-indicated for MRI.<br><br>MRCP+ v1 has the following contra- indications. MRCP+ v1 reports should not be used as the sole basis for forming a diagnosis - to do so would constitute a misuse of the device. MRCP+ v1 reports should not be used as a control mechanism for biopsy guidance – to do so would constitute a misuse of the device. MRCP+ v1 reports should not be used as a direct control mechanism for delivery of treatment – to do so would constitute a misuse of the device. MRCP+ v1 reports should not be used as the sole basis for evaluating the response to treatment - to do so would constitute a misuse of the device. | | Device User | Trained Perspectum Operators specifically trained in radiological anatomy. | Trained operator with a background in radiological anatomy, such as an MR radiographer/ MR technician. | | Report User | Same as predicate | Interpreting physician reporting radiologist | | Device Use<br>Environment | Same as predicate | Installation of MRCP+ v1 is controlled and installed on general purpose workstations at Perspectum's image analysis centre. In the context of use, MRCP+ v1 reports are made available through QAS. | | Clinical Setting | Same as predicate barring the change to device user. | The MRCP+ v1 device is a standalone software device and prior to use shall be installed on general use workstations at the manufacturer's facilities. The intended users (trained radiographers) will log on to the workstations, access the device, and use the device on general use HD monitors.<br>The intended end users of MRCP+ v1 are clinicians or expert radiologists who receive and interpret MRCP+ v1 report through the QAS portal where DICOM data is uploaded and reports are downloaded. | | Anatomical<br>Location | Same as predicate | MRCP+v1 uses acquired MR images of the mid-abdominal area in humans.<br><br>MRCP+ v1 is intended to be used in the assessment of the biliary tree and gallbladder structures and has quantification tools for | | | | | | | | interactive segmentation and labelling of<br>these structures. | | Energy<br>Considerations | Same as predicate | Software only application. The device, a<br>standalone software application, does not<br>deliver or depend on energy delivered to or<br>from patients. | | Design: Purpose | Same as predicate | Standalone software application to facilitate<br>the import and visualization of MR data sets<br>encompassing the abdomen, including the<br>liver with functionality independent of the MRI<br>equipment vendor.<br>Combining image viewing, processing and<br>reporting tools, the metrics provided is<br>designed to support physicians in the<br>visualization, evaluation and reporting of<br>hepatobiliary structures. | | Design: Tools | MRCP+ v2 calculates quantitative three-<br>dimensional biliary system models that enable<br>measurement of bile duct widths and<br>automatic detection of regions of variation<br>(ROV) in width of tubular structures.<br>MRCP+ v2 includes tools for interactive<br>segmentation and identification of the biliary<br>system and tubular structures. MRCP+ v2<br>allows for regional volumetric analysis of<br>segmented tree-like, tubular structures and<br>the gallbladder.<br>MRCP+ v2 includes tools for the removal of<br>Gastro-Intestinal (GI) contamination from<br>incoming MRCP data.<br>MRCP+ v2 also includes tools for improved<br>operability, allowing operators to select and<br>name a duct from a dropdown list. This<br>replaces the manual step of typing the duct | MRCP+ v1 calculates quantitative three-<br>dimensional biliary system models that enable<br>measurement of bile duct widths and<br>automatic detection of regions of variation<br>(ROV) of tubular structures.<br>MRCP+ v1 includes tools for interactive<br>segmentation and identification of the biliary<br>system and tubular structures. MRCP+ v1<br>allows for regional volumetric analysis of<br>segmented tree-like, tubular structures and<br>the gallbladder. | | Performance<br>Features | name under analysis.<br>Same as predicate | Main software features:<br>• Post-processing, display and allow<br>manipulation of medical MR images<br>• Image loading and saving<br>• Session file loading and saving<br>• Image viewing<br>• Image manipulation<br>• Image analysis<br>• Image processing | | Design:<br>Algorithms | Same as predicate | MRCP+ uses algorithms to:<br>• Identify the gallbladder<br>• Identify and enhance tubular structures<br>• Remove shape based small objects | | Design:<br>Gallbladder<br>Segmentation | Same as predicate | Adding and removing branches from the<br>Biliary Tree<br>Estimate tube width and other metrics such<br>as duct length<br>MRCP+ v1 supports semi-automatic<br>segmentation of the gallbladder form the<br>Biliary tree.<br>Automatic gallbladder identification is<br>completed by the MRCP+ v1 device and is<br>reviewed and modified by the operator where<br>necessary. Segmentation is completed by the | | Design:<br>Visualization | Numerous views (2D and 3D) in the MRCP+ v2<br>interface can be used to assist analysis. These<br>include:<br>• Enhanced MRCP volume<br>• Quantitative biliary tree model with the<br>duct width color map and with the<br>strictures and dilatations color map<br>• maximum Intensity Projection (MIP) of the<br>biliary tree<br>• Unfolded duct width graphic<br>Operators can see live views of crosshair<br>placements during landmarking across<br>multiple image planes simultaneously and<br>adjust contrast where required.<br>Operators will be required to navigate through<br>the axial, sagittal and coronal planes using the<br>crosshair tool to confirm that the 3D<br>visualization of the biliary tree is accurate.<br>Operators will be able to remove Gastro-<br>Intestinal (GI) contamination from incoming<br>MRCP data.<br>Operators will be able to select and name a<br>duct from a dropdown list. This replaces the<br>manual step of typing the duct name under<br>analysis. | MRCP+ v1 device.<br>Numerous views (2D and 3D) in the MRCP+ v1<br>interface can be used to assist analysis. These<br>include:<br>• Enhanced MRCP volume<br>• Quantitative biliary tree model with the<br>duct width colour map<br>• maximum Intensity Projection (MIP) of the<br>biliary tree<br>• Unfolded duct width graphic<br>Operators can see live views of crosshair<br>placements during landmarking across<br>multiple image planes simultaneously and<br>adjust contrast where required.<br>Operators will be required to navigate<br>through the axial, sagittal and coronal planes<br>using the crosshair tool to confirm that the 3D<br>visualization of the biliary tree is accurate. | | Design:<br>Supported<br>Modalities | Same as predicate | DICOM 3.0 compliant MR data. | | Design: Output | Reporting<br>Quantified metrics and images derived from<br>the analysis of the biliary tree are exported<br>from MRCP+ v2 are collated and delivered<br>into a report to be evaluated and interpreted<br>by a licensed physician.<br> | Reporting<br>Quantified metrics and images derived from<br>the analysis of the biliary tree are exported<br>from MRCP+ v1 are collated and delivered into<br>a report to be evaluated and interpreted by a<br>licensed physician.<br> | | Images of the whole biliary tree are<br>represented in 4 images within the report:<br>Enhanced MRCP volume Quantitative biliary tree model with the duct width color map with the strictures and dilatations color map A maximum Intensity Projection (MIP) of the biliary tree | Images of the whole biliary tree are<br>represented in 3 images within the report:<br>Enhanced MRCP volume Quantitative biliary tree model with the duct width colour map A maximum Intensity Projection (MIP) of the biliary tree…