LiverMultiScan (LMSv3)

K190017 · Perspectum Diagnostics, Ltd. · LNH · Jun 27, 2019 · Radiology

Device Facts

• Record ID: K190017
• Device Name: LiverMultiScan (LMSv3)
• Applicant: Perspectum Diagnostics, Ltd.
• Product Code: LNH · Radiology
• Decision Date: Jun 27, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic device software application for noninvasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times. 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. 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 includes 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 three-point Dixon methodology. These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis.

Device Story

LMSv3 is a standalone software application for post-processing DICOM 3.0 MR image datasets of the abdomen. It enables automated liver segmentation and ROI placement to quantify liver tissue characteristics (PDFF, T2*, cT1). The device transforms raw MR data into parametric maps and summary reports. Used at image analysis centers by trained operators; reports are interpreted by clinicians (radiologists, gastroenterologists, hepatologists) to assist in diagnosis. It does not contact the patient or deliver energy. Benefits include noninvasive, quantitative assessment of liver tissue, aiding clinical decision-making without requiring additional patient procedures.

Clinical Evidence

Bench testing included phantom scans to verify accuracy, repeatability, and reproducibility of T1, T2*, and PDFF measurements. In-vivo volunteer studies assessed precision, inter-operator/intra-operator variability, and worst-case variability. Results demonstrated high repeatability and reproducibility across scanners. Comparison testing against the predicate (LMSv2.1) showed T1 values within 30ms, T2* within 2ms, and negligible differences in PDFF measurements, confirming performance equivalence.

Technological Characteristics

Standalone software application; runs on general-purpose workstations (Mac OS). Inputs: DICOM 3.0 MR datasets. Outputs: Parametric maps (cT1, T2*, PDFF) and PDF reports. Algorithms: Noise determination, T1/T2* mapping, phase unwrapping, water/fat mapping (IDEAL/Dixon), and automated liver segmentation. Standards: IEC 62304, IEC 62366, DICOM 3.0, ISO 14971, ISO 13485.

Indications for Use

Indicated for patients suitable for MRI scans without contraindications, for noninvasive liver evaluation including quantification of triglyceride fat fraction (PDFF), T2*, and iron-corrected T1 (cT1) measurements.

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

• LMSv2 (K172685)

Reference Devices

• MAGNETOM Aera/Skyra (K141977)
• IDEAL IQ Software Option (K103411)

Submission Summary (Full Text)

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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 seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name in a sans-serif font. The logo is simple and professional, conveying the agency's authority and mission.

Perspectum Diagnostics Ltd Jaco Jacobs Chief Quality and Regulatory Compliance Officer 23-38 Hythe Bridge Street Oxford, Oxfordshire OX1 2ET UNITED KINGDOM

Re: K190017

Trade/Device Name: LiverMultiScan (LMSv3) Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: May 31, 2019 Received: June 3, 2019

Dear Jaco Jacobs:

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.

June 27, 2019

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

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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 (OS) 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) K190017

Device Name LiverMultiScan (LMSv3)

### Indications for Use (Describe)

LiverMultiScan (LMSv3) is indicated for use as a magnetic device software application for noninvasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times.

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.

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 three-point Dixon methodology.

These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis.

| Type of Use (Select one or both, as applicable) |
|----------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
| <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/3/Picture/2 description: The image shows the logo for Perspectum Diagnostics. The word "Perspectum" is written in a bold, dark gray font on the top line. Below that, the word "Diagnostics" is written in a lighter gray font. To the right of the words is a colorful circular logo with yellow, green, blue, and pink sections.

Date Prepared: 26th June 2019

# 1. Submitter Details

| Owner Address: | Perspectum Diagnostics Ltd<br>23-38 Hythe Bridge Street<br>Oxford,<br>Oxfordshire,<br>OX1 2ET<br>United Kingdom |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Owner/Operator Number: | 10056574 |
| Establishment Registration Number: | 3014232555 |
| Contact Person: | Dr Jaco Jacobs<br>[e-mail]<br>[phone] |

# 2. Subject and Predicate Device

| | Subject Device | Predicate Device |
|----------------------|--------------------------------------|--------------------------------------|
| 510(k) number | K190017 | K172685 |
| Legal Manufacturer | Perspectum Diagnostics Ltd | Perspectum Diagnostics Ltd |
| Owner/Owner Operator | Perspectum Diagnostics Ltd | Perspectum Diagnostics Ltd |
| Device Name | LMSv3 | LMSv2 |
| Proprietary/Common | LiverMultiScan | LiverMultiScan |
| Panel | Radiology | Radiology |
| Regulation | 21 CFR 892.1000 | 21 CFR 892.1000 |
| Risk Class | Class II | Class II |
| Product Class code | LNH | LNH |
| Classification | Magnetic Resonance Diagnostic Device | Magnetic Resonance Diagnostic Device |

# 3. Subject Device Description

LiverMultiScan (LMSv3) is a standalone software application for displaying 2D Magnetic Resonance (MR) medical image data acquired from compatible MR Scanners. LiverMultiScan runs on general-purpose workstations with a colour monitor, keyboard and mouse.

The main functionality of LiverMultiScan (LMSv3) includes:

- . Reading DICOM 3.0 compliant datasets stored on workstations, and display of the data acquisition information
- Post-processing of MRI data to generate parametric maps of Proton Density Fat Fraction PDFF), T2*, T1 and ironcorrected T1 (cT1) of the liver.
- Quantification, and calculation of PDFF, T2* and cT1 metrics using tools such as automatic liver segmentation and ROI (region of interest) placement.

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Image /page/4/Picture/1 description: The image is a logo for Perspectum Diagnostics. The word "Perspectum" is in bold, black font, and the word "Diagnostics" is in a smaller, gray font. To the right of the words is a colorful circle with four different colors: yellow, blue, green, and pink.

- Generation of a summary report demonstrating the quantitative assessment results of fat fraction in the liver ● (PDFF), T2* and iron-corrected T1 (cT1).
LiverMultiScan (LMSv3) is intended to be used by trained operators. Reports generated by trained operators are intended for use by interpreting clinicians, including, but not limited to, radiologists, gastroenterologists, and hepatologists.

LiverMultiScan (LMSv3) is intended to be used as an aid to diagnosis. The results demonstrated by LMSv3 shall only be used as an additional input to existing procedures and diagnostic workflows. The responsibility for diagnosis and treatment decisions remains with the clinicians.

LiverMultiScan (LMSv3) is a post-processing, standalone software device which has no direct contact with the human body.

LiverMultiScan (LMSv3) presents a moderate level of concern.

Intended Use

## Subject Device, LMSv3

"LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic device software application for noninvasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times.

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.

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 includes 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 three-point Dixon methodology.

These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis."

# 4. Subject and Predicate Comparison

#### 4.1. Intended Use Comparison

The subject device and the predicate device are both indicated for use in the non-invasive evaluation of the liver, which enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times. Both devices are designed to utilize DIXCOM 3.0 data as input and provide a range of tools to display and process data to determine triglyceride fat fraction in the liver, T2* and iron-corrected T1 measurements.

#### 4.2. Subject and Predicate Device Comparison

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

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Image /page/5/Picture/1 description: The image is a logo for Perspectum Diagnostics. The word "Perspectum" is in bold, black font, and the word "Diagnostics" is in a smaller, gray font. To the right of the words is a circular logo with four different colored sections: yellow, green, blue, and pink. The logo is a ring with a gap in the middle, and the pink section is a half-circle.

| Comparison of subject and Predicate Device | | |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | LMSv3 (Subject device) | LMSv2 (Predicate device) |
| Intended Use<br>and Indications<br>for Use | "LiverMultiScan (LMSv3) is indicated for use as a<br>magnetic resonance diagnostic device software<br>application for non-invasive liver evaluation that<br>enables the generation, display and review of 2D<br>magnetic resonance medical image data and<br>pixel maps for MR relaxation times.<br><br>LiverMultiScan (LMSv3) is designed to utilize<br>DICOM 3.0 compliant magnetic resonance image<br>datasets, acquired from compatible MR Systems,<br>to display the internal structure of the abdomen<br>including the liver. Other physical parameters<br>derived from the images may also be produced.<br><br>LiverMultiScan (LMSv3) provides a number of<br>tools, such as automated liver segmentation and<br>region of interest (ROI) placements, to be used<br>for the assessment of selected regions of an<br>image. Quantitative assessment of selected<br>regions includes the determination of<br>triglyceride fat fraction in the liver (PDFF), T2*<br>and iron-corrected T1 (cT1) measurements. PDFF<br>may optionally be computed using the LMS<br>IDEAL or three-point Dixon methodology.<br><br>These images and the physical parameters<br>derived from the images, when interpreted by a<br>trained clinician, yield information that may<br>assist in diagnosis." | "LiverMultiScan is indicated for use<br>as a magnetic resonance diagnostic device<br>software application for non-invasive liver<br>evaluation that enables the generation, display<br>and review of 2D magnetic resonance medical<br>image data and pixel maps for MR relaxation<br>times.<br><br>LiverMultiScan is designed to utilize DICOM 3.0<br>compliant magnetic resonance image datasets,<br>acquired from compatible MR Systems, to<br>display the internal structure of the abdomen<br>including the liver. Other physical parameters<br>derived from the images may also be produced.<br><br>LiverMultiScan provides a number<br>of quantification tools, such as Region of Interest<br>(ROI) placements, to be used for the assessment<br>of regions of an image to quantify liver tissue<br>characteristics, including the determination<br>of triglyceride fat fraction in the liver, T2* and<br>iron-corrected T1 measurements.<br><br>These images and the physical parameters<br>derived from the images, when interpreted by a<br>trained clinician, yield information that may<br>assist in diagnosis." |
| Target<br>Population | Patients suitable to undergo an MRI scan and not<br>contra-indicated for MRI. | Patients suitable to undergo an MRI scan and not<br>contra-indicated for MRI. |
| Device User | Trained PD operator | Trained PD operator |
| Report User | An interpreting clinician or healthcare<br>practitioner | An interpreting clinician or healthcare<br>practitioner |
| Device Use<br>Environment | Installation of LMSv3 is controlled and installed<br>on general purpose workstations at PD's image<br>analysis centre | Installation of LMSv2 is controlled and installed<br>on general purpose workstations at PD's image<br>analysis centre |
| Clinical Setting | LMSv3 is a standalone software device that's<br>intended to be installed on general use<br>workstations at PD's image analysis centre. The<br>intended device users will log on to the | LMSv2 is a standalone software device that's<br>intended to be installed on general use<br>workstations at PD's image analysis centre. The<br>intended device users will log on to the |
| Comparison of subject and Predicate Device | | |
| Characteristic | LMSv3 (Subject device) | LMSv2 (Predicate device) |
| | workstations, access the device, and use the<br>device on general-use HD monitors. | workstations, access the device, and use the<br>device on general-use HD monitors. |
| | LMSv3 is a post-processing software, the<br>intended device users are trained internal PD<br>operators. | LMSv2 is a post-processing software, the<br>intended device users are trained internal PD<br>operators. |
| | The end-users for the output from the device,<br>the pdf report, are clinicians who receive and<br>interpret LMSv3 reports. | The end-users for the output, the pdf report, are<br>clinicians who receive and interpret LMSv2<br>reports. |
| Anatomical<br>Location | Abdomen, Liver | Abdomen, Liver |
| Energy<br>Considerations | Software only application. The device, a<br>standalone software application, does not<br>deliver, monitor or depend on energy delivered<br>to or from patients. | Software only application. The device, a<br>standalone software application, does not<br>deliver, monitor or depend on energy delivered<br>to or from patients. |
| Design:<br>Purpose | Standalone software application to facilitate the<br>import and visualization of MR data sets<br>encompassing the abdomen, including the liver<br>with functionality independent of the MRI<br>equipment vendor.<br><br>Software application intended to display and<br>visualize 2D multi-slice, spin-echo MR data sets<br>encompassing the abdomen. The user may<br>process, and review DICOM 3.0 compliant<br>datasets within the system. | Standalone software application to facilitate the<br>import and visualization of MR data sets<br>encompassing the abdomen, including the liver<br>with functionality independent of the MRI<br>equipment vendor.<br><br>Software application intended to display and<br>visualize 2D multi-slice, spin-echo MR data sets<br>encompassing the abdomen. The user may<br>process, and review DICOM 3.0 compliant<br>datasets within the system and/or across<br>computer networks. |
| Design: Tools | Allows for the visualisation via parametric maps<br>and quantification of metrics (cT1, T2* and PDFF)<br>from liver tissue and exportation of results &<br>images to a deliverable pdf report*.<br><br>LMSv3 allows for:<br>cT1 ROI placed method on the cT1 map with IQR<br>and median metrics from the placed ROI's<br>potentially across multiple acquired slices. Full segmentation of the outer liver contour<br>and liver vasculature of the cT1 parametric<br>map. IQR and median metrics are reported<br>from the segmentation. T2* ROI placed method on the T2* map with<br>IQR and median metrics from the placed<br>ROI's potentially across multiple acquired | Allows for the visualisation via parametric maps<br>and quantification of metrics (cT1, T2* and PDFF)<br>from liver tissue and exportation of results &<br>images to a deliverable pdf report.<br><br>LMSv2 allows for:<br>cT1 ROI placed method on the cT1 map with IQR<br>and median metrics from the placed ROI's<br>potentially across multiple acquired slices. T2* ROI placed method on the T2* map with<br>IQR and median metrics from the placed |
| Comparison of subject and Predicate Device | | |
| Characteristic | LMSv3 (Subject device) | LMSv2 (Predicate device) |
| | slices T2* parametric maps are calculated<br>from the Gradient Multi-Echo method.<br><br>PDFF ROI placed method on the PDFF map with<br>IQR and median metrics from the placed<br>ROI's potentially across multiple acquired<br>slices potentially across multiple acquired<br>slices. PDFF parametric maps can be calculated<br>using either the LMS IDEAL method [2] or<br>the three-point DIXON method. [1] Full liver segmentation of the PDFF<br>parametric map where IQR and median<br>metrics are reported from the<br>segmentation. | ROI's potentially across multiple acquired<br>slices T2* parametric maps are calculated<br>from the Gradient Multi-Echo method.<br><br>PDFF ROI placed method on the PDFF map with<br>IQR and median metrics from the placed<br>ROI's potentially across multiple acquired<br>slices potentially across multiple acquired<br>slices. PDFF parametric maps are calculated from<br>the three-point DIXON method. [1] |
| Design:<br>Algorithms | Previously cleared algorithms:<br>Noise Determination Algorithms T1 mapping Algorithms T2* mapping Algorithms Unwrapping Phase Image Algorithms Creation of cT1 image Algorithms Water and Fat Mapping Algorithms New algorithms: IDEAL Processing Algorithms MAGO Processing Algorithms Quality Check for Shimming Automatic Liver Segmentation Algorithms Segmentation Mapping to T2*/PDFF<br>algorithms LMSv3 uses identical algorithms cleared in LMSv2<br>to quantify cT1, T2* and DIXON PDFF using ROI's. | Noise Determination Algorithms T1 mapping Algorithms T2* mapping Algorithms Unwrapping Phase Image Algorithms Creation of cT1 image Algorithms Water and Fat Mapping Algorithms |
| Design: MR<br>Relaxometry | T1, iron-corrected T1 (cT1) and T2* mapping. | T1, iron-corrected T1 (cT1) and T2* mapping. |
| Design: Liver<br>Fat<br>Quantification | Utilizes MR images that exploit the difference in<br>resonance frequencies between hydrogen nuclei<br>in water and triglyceride fat using either LMS<br>IDEAL method or three-point DIXON method. | Utilizes MR images that exploit the difference in<br>resonance frequencies between hydrogen nuclei<br>in water and triglyceride fat using the three-<br>point DIXON method. |
| Comparison of subject and Predicate Device | | |
| Characteristic | LMSv3 (Subject device) | LMSv2 (Predicate device) |
| Design: Liver<br>Segmentation | LMSv3 supports automatic multi-slice full liver<br>segmentation of the cT1 and PDFF parametric<br>map. Use of this functionality is at the discretion<br>of the operator instead or in combination with<br>the ROI based method.<br><br>The cT1 segmented liver is presented in colour<br>level window, while the rest of the cT1 image is<br>presented in greyscale level window with ducts<br>and liver vasculature excluded from the<br>segmented volume. | Does not support whole liver segmentation. See<br>first reference device below, LiverLab. |
| Design: Regions<br>of Interest<br>(ROI) | Median and interquartile range measurements<br>created from a cross sectional slice of liver<br>tissue. For each parametric map, statistics from<br>multiple Regions of Interest (ROIs) — potentially<br>placed across multiple slices – are summarised.<br><br>Also supports the display of 'Live' ROI statistics<br>when moving the ROI across the parametric<br>map. | Median and interquartile range measurements<br>cre…