Who is the manufacturer of CoverScan (CoverScan v1.1)?

Perspectum filed the 510(k) submission for CoverScan (CoverScan v1.1) (K230294).

What is the FDA product code for CoverScan (CoverScan v1.1)?

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 (CoverScan v1.1)?

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

Who can help prepare an FDA 510(k) submission like CoverScan (CoverScan v1.1)?

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 (CoverScan v1.1)

K230294 · Perspectum · LLZ · Mar 3, 2023 · Radiology

Device Facts

Record ID	K230294
Device Name	CoverScan (CoverScan v1.1)
Applicant	Perspectum
Product Code	LLZ · Radiology
Decision Date	Mar 3, 2023
Decision	SESE
Submission Type	Special
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 post-processing 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 (T1, srT1, 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 images, when interpreted by a licensed physician, yield information that may assist in diagnosis, clinical management and monitoring of patients.

Device Story

CoverScan v1.1 is a post-processing software system for DICOM-compliant MR data; processes images to quantify tissue characteristics and organ function (heart, lungs, liver, spleen, pancreas, kidney). Inputs: MR images from Siemens 1.5T/3T scanners. Operation: software modules perform segmentation, relaxometry (T1, T2, T2*), and fat fraction (PDFF) mapping using IDEAL methodology; cardiac modules calculate ejection fraction, volumes, and mass. Used in clinical settings by trained internal operators at Perspectum image centers; outputs are quantitative reports for clinician interpretation. Benefits: assists in diagnosis, clinical management, and monitoring of patients by providing standardized, quantified organ metrics.

Clinical Evidence

Bench testing only. Performance assessed using purpose-built phantoms and in-vivo acquired data from volunteers covering a range of physiological values for sT1, cT1, T1, and PDFF. Verification and validation testing confirmed product specifications and system capabilities.

Technological Characteristics

Post-processing software; runs on Mac OS workstations. Supports DICOM 3.0 MR data. Implements IDEAL (Iterative Decomposition of water and fat with Echo Asymmetric and Least-squares estimation) for PDFF. Standards: IEC 62304, IEC 62366, ISO 14971, ISO 13485.

Indications for Use

Indicated for patients requiring analysis of DICOM-compliant MR images of the heart, lungs, liver, spleen, pancreas, and kidney. Not intended for asymptomatic screening. Intended for use with Siemens 1.5T and 3T MRI scanners.

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

CoverScan v1.0 (K212565)

Related Devices

K212565 — CoverScan v1 · Perspectum, Ltd. · May 19, 2022
K143020 — LiverMultiScan · Mirada Medical, Ltd. · Jun 23, 2015
K172685 — LiverMultiScan · Perspectum Diagnostics, Ltd. · Nov 21, 2017
K202170 — LiverMultiScan · Perspectum, Ltd. · Oct 2, 2020
K253413 — LiverMultiScan (v6.0) · Perspectum, Ltd. · Mar 9, 2026

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below. March 3, 2023 Perspectum Ltd. % Ioan Wigley Head of Regulatory Affairs Gemini One 5220 John Smith Drive Oxford, Oxfordshire OX4 2LL United Kingdom Re: K230294 Trade/Device Name: CoverScan (CoverScan v1.1) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: November 28, 2022 Received: February 2, 2023 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. {1}------------------------------------------------ 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 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. Dghk Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use Submission Number (if known) K230294 Device Name CoverScan (CoverScan v1.1) Indications for Use (Describe) 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. 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 (T1. srT1. 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 images, when interpreted by a licensed physician, yield 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 and Siemens 3T 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}------------------------------------------------ RA0913 Image /page/3/Picture/2 description: The image shows the logo for Perspectum. The word "Perspectum" is written in a bold, sans-serif font in blue color. To the right of the word is a circular graphic divided into four colored sections: light blue, green, pink, and dark blue. The logo has a clean and modern design. K230294 | Date Prepared: | 28 November 2022 | |----------------|------------------| |----------------|------------------| ## Submitter Details Owner Address: Gemini One, 5520 John Smith Drive, Oxford Business Park, Oxford. OX4 2LL Perspectum Ltd Contact Person: loan Wigley # Subject and Predicate Device | | Predicate Device | Subject Device | |-------------------------|----------------------------------------|----------------------------------------| | 510(k) number | K212565 | Unknown | | Legal Manufacturer | Perspectum Ltd. | Perspectum Ltd. | | Owner/Operator Number | 10056574 | 10056574 | | Device Name | CoverScan v1.0 | CoverScan v1.1 | | Proprietary/Common name | CoverScan | CoverScan | | 510k Review Panel | Radiology | Radiology | | Regulation Number | 892.2050 | 892.2050 | | Risk Class | Class II | Class II | | Product Class code | LLZ | LLZ | | Classification | System, Image Processing, Radiological | System, Image Processing, Radiological | ## Device Name | Device Trade Name | Common Name | |-------------------|-------------------------| | CoverScan v1.1 | CoverScan, CoverScan v1 | # 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. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the word "Perspectum" in a bold, sans-serif font. The word is colored in a dark blue. To the right of the word is a circular logo that is divided into four sections. The top three sections are colored light blue, green, and pink, while the bottom section is colored dark blue. Metrics produced by CoverScan can be used by healthcare professionals (HCPs) in a clinical setting for the purposes of assessing multiple organs. CoverScan v1.1 is a new version of CoverScan that supports the use of Siemens 3T scan data to enable more scan sites to utilise CoverScan. # Intended 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. 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 (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 images, when interpreted by a licensed physician, yield information that may assist in diagnosis, clinical management and monitoring of patients. # Indications for use CoverScan is not intended for asymptomatic screening. This device is intended for use with Siemens 1.5T and 3T MRI scanners. # Substantial equivalence The modified CoverScan v1.1 device has the following similarities to the previously cleared CoverScan v1 device. | Characteristic | Subject and Predicate Device Comparison | | |----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | CoverScan v1.0 (Predicate device) | CoverScan v1.1 (Subject Device) | | Product Code | LLZ | LLZ | | Regulation Number | 892.2050 | 892.2050 | | Class | II | II | | 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, 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 images, when interpreted by a licensed physician, yield information that may assist in diagnosis, clinical management and monitoring of patients. | 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. 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 (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 images, when interpreted by a licensed physician, yield information that may assist in diagnosis, clinical management and monitoring of patients. | | Indications for use | CoverScan is not intended for asymptomatic screening. This device is intended for use with Siemens 1.5T MRI scanners | CoverScan is not intended for asymptomatic screening. This device is intended for use with Siemens 1.5T and Siemens 3T MRI scanners. | | The Subject device underwent additional performance testing to show that the performance was the same as the predicate. | | | | Limitations of Use | Indicated where MRI is not contraindicated. | Same as predicate | | Device Users | Trained Perspectum internal operators. | Same as predicate | | Use Environment | Installation of Modules 1-5 of CoverScan are installed on general purpose workstations at Perspectum's image | | | | Module 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 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. 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. The end-users for the output from the device, the report, are clinicians who receive and interpret reports. | Same as predicate | | 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. | Same as predicate | | | 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. 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 | Same as predicate | {5}------------------------------------------------ Image /page/5/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 that is divided into several colored sections. The top half of the circle is divided into three sections colored light blue, green, and pink. The bottom half of the circle is a solid dark blue color. analysis centre by specialist members of staff. Workstations need to meet the minimum technical requirements. Same as predicate. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the word "Perspectum" in a bold, sans-serif font. The word is in a dark blue color. To the right of the word is a circular logo that is divided into four sections. The top left section is light blue, the top right section is pink, the bottom section is dark blue, and the middle section is green. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the word "Perspectum" in a dark blue font. To the right of the word is a circular logo that is divided into four colored sections: light blue, green, pink, and dark blue. The dark blue section of the logo also contains a smaller, concentric circle within it. | PDFF parametric maps are calculated using the LMS IDEAL method (1) | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------| | Module 2 (Pancreas module) sT1 | | | ROI placed method on the T1 map with IQR and median metrics from the placed ROIs potentially across multiple acquired slices PDFF 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) | Same as predicate | | Module 3 (Kidney module) T1 ROI placed method on the T1 map with IQR and median metrics from the placed ROIs potentially across multiple acquired slices | Same as predicate | | 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 | Same as predicate | {8}------------------------------------------------ Image /page/8/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 that is divided into four sections. The top three sections are colored light blue, green, and pink, while the bottom section is dark blue. The logo is meant to represent a global perspective. | | Stroke Volume Left Ventricle Muscle Mass Left Ventricular Wall Thickness Global and regional LV function and volume analysis Global RV function analysis T1 mapping Module Assessment of native and post contrast T1 Relaxation times T1, T1*and R2 maps with customizable color LUT and polar map display Assessment of ECV % per slice and segment including polar map display and map generation with customizable color LUT T2 Mapping Module Global and Regional Segmental T2 times | | |-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------| | | Module 5 (Lung) Basic calculations to determine the percentage change in area from inspiration to expiration from datasets exported from analysis conducted in Osirix MD. | Same as predicate | | | Module 6 (Metric consolidation) A compiled clinical report containing metrics from modules 1-5, rounding of these numbers along with a reference range. Basic logic algorithm applied to determine if there is evidence of heart impairment from cardiac metrics exported from analysis conducted. | Same as predicate | | Performance Features | Main software features: Post-processing, display and allow manipulation of medical MR images Image loading and saving Session file loading and saving Image viewing Image manipulation Image analysis Image processing Relaxometry post-processing Fat fraction postprocessing Segmentation of regions of interest | Same as predicate | | Design: MR Relaxometry | Relaxometry post-processing (T1, T2 and T2*). And subsequently cT1 and sT1. | Same as predicate | | Design: Liver Fat Quantification | Fat fraction postprocessing (PDFF) | Same as predicate | | Design: Parametric Maps | An operator can use modules 1-3 of CoverScan to generate T2*, T2 and T1 relaxometry maps fitted from an appropriate set of MR Inversion Recovery images which are Gradient Echo (GRE) and MOLLI acquisition protocols respectively. Modules within CoverScan may also be used to generate fat signal fraction (PDFF) maps calculated from an appropriate set of MR GRE images using the IDEAL (iterative decomposition of water and fat with echo asymmetric and least-squares estimation) methodology (13). Module 5 within CoverScan can be used to calculate percentage change in area from inspiration to expiration change using the interface that offers tools: 3D rendering tools, such as Multiplanar Reconstructions, Curved Reconstructions, 3D Volume Rendering, 3D Surface Rendering, 3D Endoscopy 3D sculpting tools Measure distance in 3D Volume Rendering, 3D Curved-MPR or 3D Orthogonal MultiPlanar 3D rigid registration Module 4 within CoverScan can be used to analyse and calculate cardiac metrics to report: 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 Global RV function analysis Assessment of native and post contrast T1 Relaxation times T1, T1* and R2 | Same as predicate | | | Assessment of ECV % per slice and segment Global and Regional Segmental T2 times | | | Design: Visualisation | Offers numerous views within modules 1-5 of the CoverScan interface can be used to assist in analysis, T1, T2* and Proton Density Fat Fraction (PDFF)) parametric maps can be created from all supported scanners. R2 maps can also be utilised to assess the quality of the map fitting. Colormaps in the parametric maps are designed to have maximum contrast on organ tissue. | Same as predicate | | Design: Outputted data | Quantified metrics and images derived from the analysis of liver tissue characteristic on parametric maps are collated into a datafile that may subsequently be assembled into a report for evaluation and interpretation by a clinician. Based on the placed ROI's (during analysis in Modules 1-3), for each metric the median and IQR are given as well as a 'reference range'. | Same as predicate | | Design: Supported Modalities | DICOM 3.0 compliant MR data from supported MRI scanners. | Same as predicate | | Performance Testing | Perspectum has conducted extensive validation testing of CoverScan, a medical image management and processing system (MIMPS), that is capable of providing reliable post-processing and display of images for instantaneous multi- parametric analysis. Internal verification and validation testing confirms that the product specifications are met. All of the different components of the CoverScan software have been stress tested to ensure that the system as a whole provides all the capabilities necessary to operate according to its intended use. The main groups of tests performed include: Product Risk Assessment Software modules verification tests Software validation test Device performance was assessed with purpose-built phantoms and in-vivo acquired data from volunteers covering a range of physiological values for sT1, cT1, T1 and PDFF. | Same as predicate | | Human Factors | Assessed in accordance with IEC 62366 and FDA guidance document 'Applying Human Factors and Usability Engineering to Medical Devices' | Same as predicate | | Standards | IEC 62304, IEC 62366, DICOM 3.0, ISO 14971, ISO 13485 | Same as predicate | | System/Operatin g System | Mac OS | Same as predicate | | Materials | Not applicable, post-processing software | Not applicable, post-processing software | | Energy Source | Not applicable, post-processing software | Not applicable, post-processing software | | Biocompatibility | Not applicable, post-processing software | Not applicable, post-processing software | | Sterility | Not applicable, post-processing software | Not applicable, post-processing software | | Electrical Safety | Not applicable, post-processing software…