Hepatica v1 (Hepatica v1.0.0)

K203280 · Perspectum, Ltd. · LNH · Jan 12, 2021 · Radiology

Device Facts

• Record ID: K203280
• Device Name: Hepatica v1 (Hepatica v1.0.0)
• Applicant: Perspectum, Ltd.
• Product Code: LNH · Radiology
• Decision Date: Jan 12, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Hepatica (Hepatica v1) is a post-processing medical device software that presents quantified metrics which may contribute to the assessment of a patient's liver health. Hepatica (Hepatica v1) uses image visualisation and analysis tools to process DICOM 3.0 compliant magnetic resonance image datasets to produce semi-automatic segmented 3D models of the work of Couinaud and the Brisbane 2000 terminology. For each identified Couinaud segment, volumetric data is determined and reported. Hepatica v1) may also report iron corrected-T1 (cT1) and PDFF calculated using the IDEAL method from multi-slice acquisitions, on a per segment basis, over the whole liver. Both metrical values of different fundamental liver tissue characteristics that can be used as measures of liver tissue health. Hepatica (Hepatica v1) provides trained clinicians with additional information to evaluate the volume and health of a patient's liver on a segmental basis. It is not intended to replace the established procedures for the assessment of a patient's liver health. However, information gathered through existing diagnostic tests, clinical evaluation of the patient, as well Hepatica (Hepatica v1), may support surgical decision making.

Device Story

Hepatica v1 is a post-processing software that processes DICOM 3.0 MR image datasets. It generates semi-automatic 3D segmented models of the liver based on Couinaud and Brisbane 2000 terminology. The device calculates volumetric data per segment and integrates iron-corrected T1 (cT1) and PDFF metrics (imported from the predicate device) to provide a comprehensive liver health report. It is operated by trained Perspectum staff at image analysis centers on general-purpose workstations. The resulting report is provided to clinicians to assist in evaluating liver volume and health, supporting surgical decision-making. It does not replace established diagnostic procedures but provides additional quantitative information to aid clinical management of patients considered for liver resection.

Clinical Evidence

No clinical investigations were conducted. Performance was validated using previously acquired in-vivo volunteer data. Accuracy and precision (repeatability/reproducibility) were assessed by comparing device-generated volumetric, cT1, and PDFF metrics against radiologist-derived gold standards. Results showed high agreement, with variation within established acceptance criteria.

Technological Characteristics

Standalone software; non-contact/non-invasive. Operates on Mac OS workstations. Processes DICOM 3.0 MR datasets. Uses semi-automatic segmentation algorithms for 3D liver modeling. Compliant with IEC 62304, IEC 62366, ISO 14971, and ISO 13485. No electrical, electromagnetic, or biocompatibility testing required.

Indications for Use

Indicated for patients suitable for MRI scans without contraindications. Used to assist clinicians in evaluating liver volume and health on a segmental basis to support surgical decision-making.

Regulatory Classification

Identification

A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).

Special Controls

*Classification.* Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• LiverMultiScan (LMSv4) (K202170)

Submission Summary (Full Text)

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January 12, 2021

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Perspectum Ltd. % Ioan Wigley Chief Compliance Officer 5520 John Smith Drive Oxford, Oxfordshire OX4 2LL UNITED KINGDOM

Re: K203280

Trade/Device Name: Hepatica (Hepatica v1) Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: October 1, 2020 Received: November 16, 2020

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) K203280

Device Name Hepatica (Hepatica v1)

#### Indications for Use (Describe)

Hepatica (Hepatica v1) is a post-processing medical device software that presents quantified metrics which may contribute to the assessment of a patient's liver health.

Hepatica (Hepatica v1) uses image visualisation and analysis tools to process DICOM 3.0 compliant magnetic resonance image datasets to produce semi-automatic segmented 3D models of the work of Couinaud and the Brisbane 2000 terminology. For each identified Couinaud segment, volumetric data is determined and reported.

Hepatica v1) may also report iron corrected-T1 (cT1) and PDFF calculated using the IDEAL method from multi-slice acquisitions, on a per segment basis, over the whole liver. Both metrical values of different fundamental liver tissue characteristics that can be used as measures of liver tissue health.

Hepatica (Hepatica v1) provides trained clinicians with additional information to evaluate the volume and health of a patient's liver on a segmental basis. It is not intended to replace the established procedures for the assessment of a patient's liver health. However, information gathered through existing diagnostic tests, clinical evaluation of the patient, as well Hepatica (Hepatica v1), may support surgical decision making.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <span style="font-size: 10px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 10px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/1 description: The image shows the logo for Perspectum. The logo consists of the word "Perspectum" in a bold, sans-serif font, followed by a circular graphic made up of four different colored sections: yellow, blue, green, and pink. Below the logo is the text "K203280".

Date Prepared:

28th October 2020

## 1. Submitter Details

| Owner Address: | Perspectum Ltd<br>Gemini One,<br>5520 John Smith Drive,<br>Oxford Business Park,<br>Oxford,<br>OX4 2LL |
|------------------------------------|--------------------------------------------------------------------------------------------------------|
| Owner/Operator Number: | 10056574 |
| Establishment Registration Number: | 3014232555 |
| Contact Person: | Ioan Wigley |

[e-mail] [phone]

### 2. Subject and Predicate Device

| | Subject Device | Predicate Device |
|----------------------|-----------------------------------------------|-----------------------------------------------|
| 510(k) number | K203280 | K202170 |
| Legal Manufacturer | Perspectum Ltd. | Perspectum Ltd. |
| Owner/Owner Operator | 10056574 | 10056574 |
| Device Name | Hepatica (Hepatica v1) | LiverMultiScan (LMSv4) |
| Proprietary/Common | Hepatica | LiverMultiScan |
| Panel | Radiology | Radiology |
| Regulation | 892.1000 | 892.1000 |
| Risk Class | Class II | Class II |
| Product Class code | LNH | LNH |
| Classification | System, Nuclear Magnetic<br>Resonance Imaging | System, Nuclear Magnetic<br>Resonance Imaging |

### 3. Subject Device Description

#### 3.1. Intended Use

Hepatica (Hepatica v1) is a post-processing medical device software that presents quantified metrics which may contribute to the assessment of a patient's liver health.

Hepatica (Hepatica v1) uses image visualisation and analysis tools to process DICOM 3.0 compliant magnetic resonance image datasets to produce semi-automatic segmented 3D models of the liver based on the work of Couinaud and the Brisbane 2000 terminology. For each identified Couinaud segment, volumetric data is determined and reported.

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Image /page/4/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 with four different colored sections. The colors are yellow, blue, green, and pink. There is a registered trademark symbol in the upper right corner of the logo.

Hepatica (Hepatica v1) may also report iron corrected-T1 (cT1) and PDFF calculated using the IDEAL method from multi-slice acquisitions, on a per segment basis, over the whole liver. Both metrical values of different fundamental liver tissue characteristics that can be used as measures of liver tissue health.

Hepatica (Hepatica v1) provides trained clinicians with additional information to evaluate the volume and health of a patient's liver on a segmental basis. It is not intended to replace the established procedures for the assessment of a patient's liver health. However, information gathered through existing diagnostic tests, clinical evaluation of the patient, as well Hepatica (Hepatica v1), may support surgical decision making.

#### 3.2. Sterilization and Shelf Life

Hepatica v1 is a standalone software device thus it is non-contact, non-invasive and non-sterile. The shelf life of Hepatica v1 is indefinite as long as the manufacturer continues to support the device. Both sterilization and shelf life characteristics are equivalent of the predicate device.

#### 3.3. Biocompatibility

Hepatica v1 is a standalone software device thus it is non-contact and non-invasive. No biocompatibility testing was deemed necessary to demonstrate the safety and effectiveness of Hepatica v1 does not consist of materials that differ from the predicate device.

#### 3.4. Software

Hepatica v1 was successfully validated and verified against the requirements specification and its intended use. The results from the validation and verification activities, documented in this submission, corroborate that Hepatica v1 meets the product requirement specifications and intended use, which is deemed to be substantially equivalent to the predicate (see section below).

Validation and verification activities were conducted in a controlled environment and in compliance with IEC 62304:2006, ISO 13485:2016 and 21 CFR 820. Hepatica v1 is also in compliance with the DICOM standard.

#### 3.5. Electromagnetic and Electrical Safety

Hepatica v1 is a standalone software device- there are no electrical safety risks associated with the direct use of the Hepatica v1 device. No electromagnetic or electrical safety testing was deemed necessary to demonstrate the safety and effectiveness of Hepatica v1.

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# Perspectu

## 4. Subject and Predicate Comparison

#### Subject and Predicate Device Comparison 4.1.

The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence.

| Comparison of Subject and Predicate Device | | |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Hepatica v1 (Subject device) | LMSv4 (Predicate device) |
| Intended Use and<br>Indications for Use | "Hepatica (Hepatica v1) is a post-processing<br>medical device software that presents<br>quantified metrics which may contribute to<br>the assessment of a patient's liver health. | "LiverMultiScan (LMSv4) is indicated for use<br>as a magnetic resonance diagnostic device<br>software application for non-invasive liver<br>evaluation that enables the generation,<br>display and review of 2D magnetic resonance<br>medical image data and pixel maps for MR<br>relaxation times. |
| | Hepatica (Hepatica v1) uses image<br>visualisation and analysis tools to process<br>DICOM 3.0 compliant magnetic resonance<br>image datasets to produce semi-automatic<br>segmented 3D models of the liver based on<br>the work of Couinaud and the Brisbane 2000<br>terminology. For each identified Couinaud<br>segment, volumetric data is determined and<br>reported. | LiverMultiScan (LMSv4) is designed to utilize<br>DICOM 3.0 compliant magnetic resonance<br>image datasets, acquired from compatible<br>MR systems, to display the internal structure<br>of the abdomen including the liver. Other<br>physical parameters derived from the images<br>may also be produced. |
| | Hepatica (Hepatica v1) may also report iron<br>corrected-T1 (cT1) and PDFF calculated using<br>the IDEAL method from multi-slice<br>acquisitions, on a per segment basis, over<br>the whole liver. Both metrics present<br>numerical values of different fundamental<br>liver tissue characteristics that can be used<br>as measures of liver tissue health. | LiverMultiScan (LMSv4) provides a number of<br>tools, such as automated liver segmentation<br>and region of interest (ROI) placements, to<br>be used for the assessment of selected<br>regions of an image. Quantitative<br>assessments of selected regions include the<br>determination of triglyceride fat fraction in<br>the liver (PDFF), T2* and iron-corrected T1<br>(cT1) measurements. T2* may be optionally<br>computed using the DIXON or LMS MOST<br>methods. |
| | Hepatica (Hepatica v1) provides trained<br>clinicians with additional information to<br>evaluate the volume and health of a patient's<br>liver on a segmental basis. It is not intended<br>to replace the established procedures for the<br>assessment of a patient's liver health.<br>However, information gathered through<br>existing diagnostic tests, clinical evaluation of<br>the patient, as well Hepatica (Hepatica v1),<br>may support surgical decision making." | These images and the physical parameters<br>derived from the images, when interpreted<br>by a trained clinician, yield information that<br>may assist in diagnosis." |
| Target Population | Patients who are suitable to undergo an MRI<br>scan and not contra-indicated for MRI.<br>Hepatica may benefit the clinical<br>management of patients who are being<br>considered for liver resection(s). | Patients suitable to undergo an MRI scan and<br>not contra-indicated for MRI |
| Comparison of Subject and Predicate Device | | |
| Characteristic | Hepatica v1 (Subject device) | LMSv4 (Predicate device) |
| Device User | Trained Perspectum internal operator | Trained Perspectum internal operator |
| Report User | An interpreting clinician or healthcare<br>practitioner | An interpreting clinician or healthcare<br>practitioner |
| Device Use<br>Environment | Installation of Hepatica v1 is controlled and is<br>installed on general purpose workstations<br>that meet the minimum technical<br>requirements at Perspectum's image analysis<br>centre by specialist members of staff | Installation of LMSv4 is controlled and is<br>installed on general purpose workstations<br>that meet the minimum technical<br>requirements at Perspectum's image analysis<br>centre by specialist members of staff. |
| Clinical Setting | Hepatica v1 is a standalone software device<br>that is intended to be installed on general<br>use workstations at Perspectum's image<br>analysis centres. The intended device users<br>will log on to the workstations, access the<br>device, and use the device on general-use<br>HD monitors.<br>Hepatica v1 is a post-processing software<br>and the intended device users are trained | LMSv4 is a standalone software device that is<br>intended to be installed on general use<br>workstations at Perspectum's image analysis<br>centres. The intended device users will log<br>on to the workstations, access the device,<br>and use the device on general-use HD<br>monitors.<br>LMSv4 is a post-processing software and the<br>intended device users are trained |
| | Perspectum internal operators.<br>Operators use Hepatica v1 to conduct<br>quantitative analysis of liver tissue<br>characteristics to produce a report.<br>The end-users for the output from the | Perspectum internal operators.<br>Operators use LMS to conduct quantitative<br>analysis of liver tissue characteristics to<br>produce a report.<br>The end-users for the output from the |
| | device, the report, are clinicians who receive<br>and interpret Hepatica v1 reports. | device, the report, are clinicians who receive<br>and interpret LMSv4 reports. |
| Anatomical<br>Location | Abdomen, including the Liver | Abdomen, including the Liver |
| Energy<br>Considerations | Hepatica is a standalone software<br>application. It does not deliver, monitor or<br>depend on energy delivered to or from<br>patients. | LMS is a standalone software application. It<br>does not deliver, monitor or depend on<br>energy delivered to or from patients. |
| Design: Purpose | Hepatica is a standalone software application<br>that imports MR datasets encompassing the<br>abdomen, including the liver. Visualisation<br>and display of T1-weighted MR data which<br>can be analysed, and quantitative metrics of<br>tissue characteristics and liver volume are<br>then reported.<br>Datasets imported into Hepatica are DICOM<br>3.0 compliant and reported metrics are<br>independent of the MRI equipment vendor. | LMS is a standalone software application that<br>imports MR data sets encompassing the<br>abdomen, including the liver. Visualisation<br>and display of 2D multi-slice, spin-echo MR<br>data can be analysed, and quantitative<br>metrics of tissue characteristics are then<br>reported.<br>Datasets imported into LMS are DICOM 3.0<br>compliant, reported metrics are independent<br>of the MRI equipment vendor. |
| Design: Tools | Allows for the 3D visualisation of the liver<br>and quantification of metrics (cT1, PDFF and<br>volumetry) from liver tissue and exportation<br>of results and images to a deliverable report. | Allows for the visualisation via parametric<br>maps and quantification of metrics (cT1, T2*<br>and PDFF) from liver tissue and exportation<br>of results and images to a deliverable report. |
| Comparison of Subject and Predicate Device | | |
| Characteristic | Hepatica v1 (Subject device) | LMSv4 (Predicate device) |
| | Hepatica v1 allows for: | LMSv4 allows for: |
| | Volumetry Reporting of whole liver and segmental volume Semi-automatic segmentation of the outer contour of the liver Semi-automatic segmentation of the liver into Couinaud segments via placed landmarks of anatomical areas of interest | 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 across multiple acquired slices. |
| | cT1 and PDFF metrics may be quantified and loaded from LMS when analysis has been conducted on the same patient. Datasets imported from LMS contain all image analysis warnings and cautions associated with the individual analysis and are included in the hepatica report. | T2* ROI placed method on the T2* map with IQR and median metrics from the placed ROI's potentially across multiple acquired slices. T2* parametric maps are calculated from the MOST method or the three-point DIXON method (1) |
| | | 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 method (2) |
| Design: MR<br>Relaxometry | Hepatica v1 does not support quantification of metrics from MR relaxometry. If cT1 results are imported from LMS, cT1 may be reported for all individual Couinaud segments and for whole-liver analysis. Median T2* values are given from the cT1 quantification. | T1, iron- and fat- corrected T1 (cT1) and T2* mapping |
| Design: Liver Fat<br>Quantification | Liver fat quantification data is imported from the predicate device (LMSv4), where available. If PDFF results are imported from LMS, PDFF may be reported for all individual Couinaud segments as well as Whole-liver | Utilizes MR images that exploit the difference in resonance frequencies between hydrogen nuclei in water and triglyceride fat using the LMS IDEAL method (2). |
| Comparison of Subject and Predicate Device | | |
| Characteristic | Hepatica v1 (Subject device) | LMSv4 (Predicate device) |
| | contour. PDFF parametric maps are<br>calculated using the LMS IDEAL method (2). | |
| Design: Liver<br>Segmentation | Hepatica v1 supports semi-automatic liver<br>segmentation of T1-weighted volumetric<br>data.<br><br>Liver segmentation in Hepatica v1 requires<br>the placement of anatomical landmarks to<br>define the outer contours of the liver and<br>can be adjusted by the operator, where<br>necessary.<br><br>Where available, whole liver and segmental<br>cT1 and PDFF quantitative metrics derived<br>from the predicate device may be presented<br>in the final report. | LMSv4 supports automatic multi-slice full<br>liver segmentation of the cT1 and PDFF<br>parametric maps. Use of this functionality is<br>at the discretion of the operator, instead or<br>in combination, with the ROI based method.<br><br>The cT1 segmented liver is presented in<br>colour level window, while the rest of the<br>cT1 image is presented in greyscale level<br>window with liver vasculature excluded from<br>the segmented volume. |
| Design: Regions of<br>Interest (ROI) | Does not support ROI functionality. | Median and interquartile range<br>measurements created from a cross<br>sectional slice of liver tissue. For each<br>parametric map, statistics from multiple<br>Regions of Interest (ROIs) - potentially<br>placed across multiple slices - are<br>summarised.<br><br>Also supports the display of 'Live' ROI<br>statistics when moving the ROI across the<br>parametric map. |
| Design: Parametric<br>Maps | Hepatica uses volumetric datasets to create<br>2D anatomical views from all supported<br>scanners.<br><br>Where available, cT1 and PDFF parametric<br>maps are derived from the predicate device. | Iron corrected T1 (cT1), T2* and Proton<br>Density Fat Fraction (PDFF) parametric maps<br>can be created from all supported scanners.<br><br>It is possible to use the T2* and PDFF maps<br>and knowledge of the T2* and PDFF<br>measurements and the scanner field<br>strength to correct for signal changes related<br>to iron deposits, producing a cT1 map. The<br>cT1 map eliminates the effects of elevated<br>iron from the T1 measurement (3) and<br>standardizes for the fat signal across scanner<br>manufacturers.<br><br>PDFF is quantified using the LMS IDEAL<br>method. Parametric maps of T2* may be<br>optionally be computed using either the<br>three-point DIXON method or the LMS MOST<br>method. |
| | Comparison of Subject and Predicate Device | |
| Characteristic | Hepatica v1 (Subject device) | LMSv4 (Predicate device) |
| Design:<br>Visualisation | Numerous views in the Hepatica v1 interface<br>can be used to assist analysis.<br><br>Operators are able to see live views of<br>crosshair placements during landmarking<br>across multiple image planes simultaneously<br>and adjust contrast where required.<br><br>Lesion segmentation will be performed by<br>navigating through the axial slices using the<br>crosshair tool and "painting in" the segment<br>on each slice.<br><br>Operators will be required to navigate<br>through the axial, sagittal and coronal planes<br>using the crosshair tool to confirm that the<br>delineation carried out by the device is<br>accurate. The borders can be adjusted<br>accordingly.<br><br>Views of the segmented liver and lesions are<br>updated in real-time and can be rotated in a<br>3D space. Paint, eraser and zooming<br>functionalities are also available to the<br>operator.<br><br>Where available, operators can review the<br>position of cT1 and PDFF slices (derived from<br>LMSv4) within the 3D view of the liver. | Numerous views within the LMSv4 interface<br>can be used to assist in analysis, Iron-<br>corrected T1 (cT1), T2* and triglyceride fat<br>(also known as Proton Density Fat Fraction<br>(PDFF)) parametric maps can be created<br>from all supported scanners. R² maps can<br>also be utilised to assess the quality of the<br>map fitting.<br><br>Iron- corrected T1 (cT1) displayed using<br>LMSv4 colourmap, designed to have<br>maximum contrast on liver parenchymal<br>tissue. |
| Design: Supported<br>Modalities | DICOM 3.0 compliant MR data from<br>supported MRI scanners.…