Who is the manufacturer of CoverScan v1?

Perspectum, Ltd. filed the 510(k) submission for CoverScan v1 (K212565).

What is the FDA product code for CoverScan v1?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for CoverScan v1?

510(k) clearance (submission type: Traditional).

What are the predicate devices for CoverScan v1?

Olea Sphere V3.0 (K152602); LiverMultiScan (LMSv3) (K190017); Cvi42 v5.11 (K141480); Osirix MD (K101342).

Who can help prepare an FDA 510(k) submission like CoverScan v1?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CoverScan v1

K212565 · Perspectum, Ltd. · LLZ · May 19, 2022 · Radiology

Device Facts

Record ID	K212565
Device Name	CoverScan v1
Applicant	Perspectum, Ltd.
Product Code	LLZ · Radiology
Decision Date	May 19, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

CoverScan is a medical image management and processing software package that allows the display, analysis and postprocessing of DICOM compliant medical images and MR data. CoverScan provides both viewing and analysis capabilities to ascertain quantified metrics of multiple organs such as the heart, lungs, liver, spleen, pancreas and kidney. CoverScan provides measurements in different organs to be used for the assessment of longitudinal and transversal relaxation time and rate (T1, SR-T1, cT1, T2), fat content (proton density fat fraction or PDFF) and metrics of organ function (e.g., left ventricular ejection fraction and lung fractional area change on deep inspiration). These metrics derived from the interpreted by a licensed physician, vield information that may assist in diagnosis, clinical management and monitoring of patients. CoverScan is not intended for asymptomatic screening. This device is intended for use with Siemens 1.5T MRI scanners.

Device Story

CoverScan v1 is a post-processing software system for DICOM-compliant MR data. It processes images from Siemens 1.5T MRI scanners to quantify tissue characteristics and organ function. Modules perform segmentation and ROI-based analysis to calculate metrics including T1, SR-T1, cT1, T2 relaxation times, and proton density fat fraction (PDFF), as well as cardiac/lung functional metrics. The software is operated by trained internal Perspectum operators at a central facility. Outputs are compiled into a clinical report for interpretation by a licensed physician to assist in diagnosis, clinical management, and patient monitoring. The device does not control scanners or other hardware; it functions as a standalone post-processing tool.

Clinical Evidence

Bench testing only. Validation included functional verification of software installation, licensing, and feature performance. Accuracy and precision were assessed using purpose-built phantoms with vials representing physiological relaxation times. Precision across scanners was evaluated using in-vivo volunteer data. Inter- and intra-operator variability was assessed. No clinical diagnostic trials were required as the device is a post-processing tool for existing MR data.

Technological Characteristics

Post-processing software for DICOM-compliant MR data. Operates on Mac OS. Features modular architecture for multi-organ quantification (liver, heart, lung, pancreas, kidney). Employs ROI-based and segmentation-based analysis for relaxometry (T1, T2, T2*) and fat quantification (PDFF). Connectivity via DICOM 3.0. Software level of concern: Moderate. Standards: IEC 62304, IEC 62366, ISO 14971, ISO 13485.

Indications for Use

Indicated for use in patients requiring MRI-based quantitative assessment of organ metrics (heart, lungs, liver, spleen, pancreas, kidney) to assist in diagnosis, clinical management, and monitoring. Not intended for asymptomatic screening. Indicated where MRI is not contraindicated.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

Olea Sphere V3.0 (K152602)
LiverMultiScan (LMSv3) (K190017)
Cvi42 v5.11 (K141480)
Osirix MD (K101342)

Related Devices

K230294 — CoverScan (CoverScan v1.1) · Perspectum · Mar 3, 2023
K253413 — LiverMultiScan (v6.0) · Perspectum, Ltd. · Mar 9, 2026
K213960 — LiverMultiScan v5 (LMSv5) · Perspectum · Sep 6, 2022
K211983 — AMRA Profiler · Amra Medical AB · Nov 24, 2021
K173749 — AMRA Profiler · Amra Medical AB · Dec 6, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is the Department of Health & Human Services logo. The text is in blue, with "FDA" in a larger font size than the rest of the text. Perspectum Ltd. % Ioan Wigley Head of Regulatory Affairs 5520 John Smith Drive Oxford. Oxfordshire OX4 2LL United Kingdom ### Re: K212565 Trade/Device Name: CoverScan v1 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: April 14, 2022 Received: April 15, 2022 Dear Ioan Wigley: 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 (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 located 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. 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 May 19, 2022 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 mediation-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, For Thalia T. Mills, Ph.D. Director DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K212565 Device Name CoverScan v1 #### Indications for Use (Describe) CoverScan is a medical image management and processing software package that allows the display, analysis and postprocessing of DICOM compliant medical images and MR data. CoverScan provides both viewing and analysis capabilities to ascertain quantified metrics of multiple organs such as the heart, lungs, liver, spleen, pancreas and kidney. CoverScan provides measurements in different organs to be used for the assessment of longitudinal and transversal relaxation time and rate (T1, SR-T1, cT1, T2), fat content (proton density fat fraction or PDFF) and metrics of organ function (e.g., left ventricular ejection fraction and lung fractional area change on deep inspiration). These metrics derived from the interpreted by a licensed physician, vield information that may assist in diagnosis, clinical management and monitoring of patients. CoverScan is not intended for asymptomatic screening. This device is intended for use with Siemens 1.5T MRI scanners. | 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}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the word "Perspectum" in a bold, dark gray font. To the right of the word is a circular logo that is divided into four colored sections: yellow, blue, green, and pink. The logo also has a small "R" in a circle in the upper right corner. Date Prepared: 16th of May 2022 K212565 ### Submitter Details Owner Address: Perspectum Ltd Gemini One, 5520 John Smith Drive, Oxford Business Park, Oxford, OX4 2LL +44 (0) 1865 655329 | Owner/Operator Number: | 10056574 | |------------------------------------|------------------------------------------------------------------| | Establishment Registration Number: | 3014232555 | | Contact Person: | loan Wigley ioan.wigley@perspectum.com +44 (0) 1865 655329 | ### Subject and Predicate Device | | Subject Device | Primary Predicate Device | Predicate Device | | | |-------------------------|-----------------------------------------------|-----------------------------------------------|--------------------------------------------------|-----------------------------------------------|-----------------------------------------------| | | | | No. 2 | No. 3 | No. 4 | | 510(k) number | Not known | K152602 | K190017 | K141480 | K101342 | | Legal Manufacturer | Perspectum Ltd. | Olea Medical | Perspectum Ltd. | Circle | Pixmeo Sarl | | Owner/Operator Number | 10056574 | Not known | 10056574 | 3007301305 | 3012516536 | | Device Name | CoverScan v1 | Olea Sphere V3.0 | LiverMultiScan (LMSv3) | Cvi42 v5.11 | Osirix MD | | Proprietary/Common name | CoverScan | Olea Sphere V3.0 | LiverMultiScan | Cvi42 | Osirix MD v12.0 | | 510k Review Panel | Radiology | Radiology | Radiology | Radiology | Radiology | | Regulation Number | 892.2050 | 892.2050 | 892.1000 | 892.2050 | 892.2050 | | Risk Class | Class II | Class II | Class II | Class II | Class II | | Product Class code | LLZ | LLZ | LNH | LLZ | LLZ | | Classification | Picture Archiving Communications System | Picture Archiving Communications System | System, Nuclear Magnetic Resonance Imaging | Picture Archiving Communications System | Picture Archiving Communications System | {4}------------------------------------------------ ### Subject Device Description ### Device Description CoverScan is a post-processing software system comprised of several software modules. It uses acquired MR data to produce metrics of quantified tissue characteristics of the heart, lungs, liver, kidneys, pancreas and spleen. Metrics produced by CoverScan can be used by licensed physicians in a clinical setting for the purposes of assessing multiple organs. ### Intended Use & Indications for Use CoverScan is a medical image management and processing software package that allows the display, analysis and postprocessing of DICOM compliant medical images and MR data. CoverScan provides both viewing and analysis capabilities to ascertain quantified metrics of multiple organs such as the heart, lungs, liver, spleen, pancreas and kidney. CoverScan provides measurements in different organs to be used for the assessment of longitudinal and transversal relaxation time and rate (T1, SR-T1, T2), fat content (proton density fat fraction or PDFF) and metrics of organ function (e.g., left ventricular ejection fractional area change on deep inspiration). These metrics derived from the interpreted by a licensed physician, vield information that may assist in diagnosis, clinical management and monitoring of patients. CoverScan is not intended for asymptomatic screening. This device is intended for use with Siemens 1.5T MRI scanners. #### Contraindications CoverScan is indicated for use where MRI is not contraindicated. #### Intended Conditions CoverScan is not intended to be used for use on any specific disease or condition, but the information provided in the report, when interpreted by a licensed physician, may benefit the clinical management, including diagnosis and monitoring of patients. #### Standalone Software CoverScan is a post-processing software device. All operations and features are directly controlled by the CoverScan device. CoverScan does not control other firmware or software outside of the device. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the word "Perspectum" in a bold, dark gray font. To the right of the word is a circular logo that is divided into four colored sections: yellow, blue, green, and pink. There is a small registered trademark symbol in the upper right corner of the logo. ### Subject and Predicate Comparison Subject and Predicate Device Comparison The following characteristics were compared between the predicate devices in order to demonstrate substantial equivalence. | Characteristic | Subject and Predicate Device(s) Comparison | | | | | |---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | CoverScan (Subject device) | Sphere V3.0 (Primary Predicate) | LiverMultiScan (LMSv3) (Predicate Device No. 2) | Cvi42 (Predicate Device No. 3) | Osirix MD (Predicate Device No. 4) | | Product Code | LLZ | LLZ | LNH | LLZ | LLZ | | Regulation Number | 892.2050 | 892.2050 | 892.1000 | 892.2050 | 892.2050 | | Class | II | II | II | II | II | | Intended Use & Indications for Use | CoverScan is a medical image management and processing software package that allows the display, analysis and post- processing of DICOM compliant medical images and MR data. | Olea Sphere V3.0 is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard 'off-the-shelf' workstation and can be used to perform image viewing, processing, image collage and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. | LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times. | Cvi42 vascular analysis add- on is an image analysis software package add-on for evaluating CT and MR images of blood vessels. | Osirix MD is a software device intended for viewing of images acquired from CT, MR, CR, DR, US and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Images and data can be captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. | {6}------------------------------------------------ # Perspectum ( #### Characteristic #### Subject and Predicate Device(s) Comparison CoverScan provides both viewing and analysis capabilities to ascertain quantified metrics of multiple organs such as the heart, lungs, liver, spleen, pancreas and kidney. Olea Sphere V3.0 provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including a MRI (DWI) / Fiber Tracking Module and a Dynamic Analysis Module (e.g., dynamic exogenous or endogenous contrast enhanced imaging data for MRI and CT). The DWI Module is used to visualize local water diffusion properties from the analysis of diffusion weighted MRI data. The Fiber Tracking feature utilizes the directional dependency of the diffusion to display the white matter structure in the brain or more generally the central nervous system LiverMultiScan (LMSv3) is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced. {7}------------------------------------------------ | Characteristic | Subject and Predicate Device(s) Comparison | | |----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | | The Dynamic Analysis Module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast while repeating acquisitions (e.g. over time with or without variable acquisition parameters) where such techniques are useful or necessary. This functionality is referred to as: Perfusion Module – the calculation of parameters related to tissue flow (perfusion) and tissue blood volume. | | | | Permeability Module – the calculation of parameters related to leakage of injected contrast material from intravascular to extracellular space. | | {8}------------------------------------------------ # Perspectum #### Characteristic #### Subject and Predicate Device(s) Comparison CoverScan provides measurements in different organs to be used for the assessment of fibrosis and/or inflammation of an organ (T1, SR-T1, cT1, T2), fat content (proton density fat fraction or PDFF) and/or some metrics of organ function (e.g., left ventricular ejection fraction and lung fractional area change on deep inspiration). Arterial Spin Labeling (ASL) Module – the calculation of parameters related to tissue flow based on a MR technique using the water in arterial blood as endogenous tracer to evaluate the perfusion. Relaxometry Module - the calculation of parameters related to the MR longitudinal and transversal relaxation time and rate. Metabolic Module – the calculation of parameters related to the fat signal fraction based on a MR technique using opposedphase imaging. LiverMultiScan (LMSv3) provides a number of tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessment of selected regions include the determination of triglyceride fat fraction in the liver (PDFF), T2* and iron-corrected T1 (cT1) measurements. PDFF may optionally be computed using the LMS IDEAL or threepoint Dixon methodology. Combining digital image process and visualisation tools such as multiplanar reconstruction (MRP)|, thin/thick maximum intensity projection (MIP) thin and thick, inverted thin and thick, volume rendering technique (VRT), curved planner reformation, processing tools such as bone removal (based on both single energy and dual energy) table removal and evaluation tools (vessel centreline calculation, lumen calculation stenosis calculation) and reporting tools (lesion location, lesion characteristics and key images), the software {9}------------------------------------------------ # Perspectum Characteristic #### Subject and Predicate Device(s) Comparison These metrics derived from the images, when interpreted by a licensed physician, yield information that may assist in diagnosis, clinical management and monitoring of patients. These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis. package is designed to support the physician identified lesion in blood vessels and evaluation, documentation and follow up of any such lesion. It shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular CT or MR images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. Cvi42 is a software application that can be used as a stand-alone product or in a networked environment. The target population for the cvi42 is not restricted, however, image acquisition by a cardiac CT or MR scanner may limit the use Lossy compressed mammographic images and digitised film screen images must not be viewed for primary diagnosis or image interpretation. For primary diagnosis, post process DICOM "for presentation" images must be used. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. It is the users responsibility to ensure monitor quality, ambient light conditions, and image compression {10}------------------------------------------------ | Characteristic | Subject and Predicate Device(s) Comparison | | | | | |--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | CoverScan is not intended for asymptomatic screening. This device is intended for use with Siemens 1.5T MRI scanners. | | | of the device for certain sectors of the general public. | ratios are consistent with the clinical application. | | Limitations of Use | Indicated where MRI is not contraindicated. | Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. | Indicated where MRI is not contraindicated. | Patients suitable to undergo an MRI or CT scan not contra-indicated for MRI or CT. | Lossy compressed mammographic images and digitised film screen images must not be viewed for primary diagnosis or image interpretation. For primary diagnosis, post process DICOM “for presentation” images must be used. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. It is the users responsibility to ensure monitor quality, ambient light conditions, and | | Characteristic | Subject and Predicate Device(s) Comparison | | | | | | | | | | | ratios are consistent with the clinical application. | | Device Users | Trained Perspectum internal operators. | The main users of the program are medical imaging professionals who need to visualize and analyse images acquired primarily with MRI or CT systems. | Trained Perspectum internal operator. | Qualified medical professionals, experienced in examining and evaluating cardiovascular CT or MR images | No restriction on users. Osirix MD is distributed directly from the company website. | | Use Environment | Installation of Modules 1-3 of CoverScan are installed on general purpose workstations at Perspectum's image analysis centre by specialist members of staff. Workstations need to meet the minimum technical requirements. | Olea Sphere is for use in hospitals, imaging centres, radiologist reading practices by a professional who requires and is granted access to patient image, demographic and report information. | Installation of LMSv3 is controlled and is installed on general purpose workstations. Workstations need to meet the minimum technical requirements. LMSv3 is installed on workstations at Perspectum's image analysis centre by specialist members of staff. | Cvi42 is a software application that can be used as a stand-alone product or in a networked environment. | Installation of Osirix MD is controlled and is installed on general purpose workstations or in a networked environment. Workstations need to meet the minimum technical requirements. | | | Module 4-6 of CoverScan is hosted on Amazon Web Services (AWS) there is no user interface for these modules. | | | | | | Clinical Setting | CoverScan is a software device that is intended to be installed on general workstations at | Installed on PC's at the clinical site. | LMSv3 is a standalone software device that is intended to be installed on | Cvi42 is a software application that can be used as a stand-alone | Installation of Osirix MD is controlled and is installed on general | {11}------------------------------------------------ {12}------------------------------------------------ | Characteristic | Subject and Predicate Device(s) Comparison | | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Perspectum's image centre. The intended device users will log on to the workstations, access the device, and use the device on general-use HD monitors. | general use workstations at Perspectum's image analysis centre. The intended device users will log on to the workstations, access the device, and use the device on general-use HD monitors. | | | | CoverScan is a post-processing software, the intended device users are trained Perspectum internal operators. Operators use CoverScan to conduct quantitative analysis of tissue characteristics and function to produce a quantitative report. | LMSv3 is a post-processing software, the intended device users are trained Perspectum internal operators. Operators use LMSv3 to conduct quantitative analysis of liver tissue characteristics to produce a report. | Cvi42 is a post-processing software, intended device users are qualified medical professionals. Users use may use cvi42 to conduct quantitative analysis to produce a clinical report. | Osirix MD is a post- processing software. Images and data can be captured, stored, communicated, processed and displayed within the system or in a networked environment. Osirix MD can export DICOM files to CD/DVD or USB sticks, including a stand-alone cross- platform viewer to display the images. It is possible to print directly from DICOM printers images derived from Osirix MD. | | The end-users for the output from the device, the report, are clinicians who receive and interpret reports. | The end-users for the output from the device, the report, are clinicians who receive and interpret LMSv3 reports. | The end-users for the output from the device, the report, are clinicians who receive and interpret reports. | | {13}------------------------------------------------ | Characteristic | | Subject and Predicate Device(s) Comparison | | | | |----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Principles of Operation | CoverScan offers comprehensive functionality for image analysis and visualisation, CoverScan contains multiple modules for the quantitative analysis of tissue characteristics and function. Visualisation and quantification tools for image analysis depend on the module. Module 1 (Liver module) cT1 Full segmentation of the outer liver contour and liver vasculature of the cT1 parametric map. ROI placed method on the cT1 map with IQR and median metrics from the placed ROIs potentially across multiple acquired slices. | The Olea Sphere software offers comprehensive functionality for dynamic image analysis and visualization, where signal changes over time are analysed to determine various modality dependent functional parameters. Olea Sphere provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including diffusion weighted MRI (DWI) / fiber tracking, and dynamic analysis (e.g. dynamic exogenous or endogenous contrast enhanced imaging data for MRI and CT). DWI / Fiber Tracking Module: Diffusion analysis is used to visualize local water diffusion | Allows for the visualisation via parametric maps and quantification of metrics (cT1, T2* and PDFF) from liver tissue and exportation of results & images to a deliverable report. LMSv3 allows for: cT1 Full segmentation of the outer liver contour and liver vasculature of the cT1 parametric map. IQR and median metrics are reported from the segmentation. ROI placed method on the cT1 map with IQR and median metrics from the placed ROI's potentially | Cvi42 contains multiple modules for the analysis of blood vessels derived from CT and MR images. Visualisation and quantification tools for image analysis depend on the use case. When used for the analysis of cardiac images the following modules are available: | Osirix MD is a post- processing software. Images and data can be captured, stored, communicated, processed and displayed within the system or in a networked environment | {14}------------------------------------------------ | Characteristic | Subject and Predicate Device(s) Comparison | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | PDFF Full liver segmentation of the PDFF parametric map where IQR and median metrics are reported from the segmentation. ROI placed method on the PDFF map with IQR and median metrics from the placed ROIs potentially across multiple acquired slices PDFF parametric maps are calculated using the LMS IDEAL method (1) | diffusion weighted MRI data. Fiber tracking utilizes the directional dependency of the diffusion to display the white matter structure in the brain or more generally the central nervous system. Dynamic Analysis: Dynamic analysis is used for visualization and analysis of dynamic imaging, showing properties of changes in contrast while repeating acquisitions (e.g. over time with or without variable acquisition parameters) where such techniques are useful or necessary. | PDFF Full liver segmentation of the PDFF parametric map where IQR and median metrics are reported from the segmentation. ROI placed method on the PDFF map with IQR and median metrics from the placed ROI's potentially across multiple acquired slices PDFF parametric maps are calculated using the LMS IDEAL or DIXON method (1). | | Module 2 (Pancreas module) SR-T1 ROI placed method on the T1 map with IQR and median metrics from the placed ROIs potentially | This functionality includes dedicated analysis methods and visualization tools for dynamic contrast enhanced imaging data (from MRI or CT) where a bolus injection of a contrast agent material results | T2* ROI placed method on the T2* map with IQR and median metrics from the placed ROI's potentially across multiple acquired slices. | {15}------------------------------------------------ | Characteristic | Subject and Predicate Device(s) Comparison | | | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|--|--| | across multiple acquired slices The calculation of pancreas T1 maps using the MultiScan module uses the signal from supported scanners and MRI field strengths to simulate the data as it would be acquired on the reference scanner, providing improved reproducibility. The SR-T1 pipeline maps MRI-system dependent T1 images to MRI-system independent SR-T1 images and that allows comparison of SR-T1 values over a wide variety of MRI systems | in a temporal change in the signal intensity. This dynamic change in signal intensity is used to calculate functional parameters related to tissue flow (perfusion) and tissue blood volume as well as leakage (due to capillary permeability) of the injected contrast material from the intravascular to the extracellular space. This functionality is referred to as: Perfusion Module: Calculation of parameters related to tissue flow (perfusion) and tissue blood volume. | T2* parametric maps are calculated from the DIXON method (2) | | | | PDFF ROI placed method on the PDFF map with IQR and median metrics from the placed ROIs potentially | Permeability Module: Calculation of parameters related to leakage of injected contrast material from | | | | | Characteristic | Subject and Predicate Device(s) Comparison | | | | | across multiple acquired slices PDFF parametric maps are calculated using the LMS IDEAL method (1) Module 3 (Kidney module) | intravascular to extracellular space. | | | | | T1 ROI placed method on the T1 map with IQR and median metrics from the placed ROIs potentially across multiple acquired slices | This functionality also includes dedicated analysis methods and visualization tools for MR technique using the water in arterial blood as endogenous tracer to visualize tissue perfusion and evaluate blood flow non-invasively. This functionality is referred to as: Arterial Spin Labelling (ASL) Module – the calculation of parameters related to tissue flow based on a MR technique using the water in arterial blood as endogenous tracer to evaluate the perfusion. This functionality also includes dedicated analysis methods and visualization tools for MR technique using intrinsic tissue properties to visualize and evaluate tissue relaxation times and fat signal fraction. This functionality is referred to as: | | | | {16}------------------------------------------------ {17}------------------------------------------------ | Characteristic | Subject and Predicate Device(s) Comparison | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Relaxometry Module – the calculation of parameters related to the MR longitudinal and transversal relaxation time and rate Metabolic Module – the calculation of parameters related to the fat signal fraction based on a MR technique using opposed- phase imaging. | Short Axis 3D Module | | Module 4 (Cardiac function module) Operators may use modules within CoverScan to analyse and quantify cardiac images with the below capabilities: Left Ventricular function • Ejection fraction • End Diastolic Volume – left ventricle • End Systolic Volume – left ventricle • Stroke Volume • Left Ventricle Muscle Mass | | Left Ventricular function • Ejection fraction • End Diastolic Volume – left ventricle • End Systolic Volume – left ventricle • Stroke Volume • Left Ventricle Muscle Mass • Left Ventricular Wall Thickness • Global and regional LV function and volume analysis | | Characteristic | Subject and Predicate Device(s) Comparison | | | • Left Ventricular Wall Thickness T1 mapping Module Assessment of native T1 Relaxation times T1, T1*and R2 maps with customizable color LUT and polar map display | • Global RV function analysis T1 mapping Module • Assessment of native and post contrast T1 Relaxation times T1, T1*and R2 maps with customizable colour LUT and polar map display • Assessment of ECV % per slice and segment including polar map display and map generation with customizable colour LUT | | | T2 Mapping Module Assessment of segmental T2 times. | T2 Mapping Module Global and Regional Segmental T2 times | | | Module 5 (Lung) Basic calculations to determine the percentage…