Who is the manufacturer of LiverMultiScan v5 (LMSv5)?

Perspectum filed the 510(k) submission for LiverMultiScan v5 (LMSv5) (K213960).

What is the FDA product code for LiverMultiScan v5 (LMSv5)?

LNH. It is classified under 21 CFR 892.1000 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for LiverMultiScan v5 (LMSv5)?

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

Does LiverMultiScan v5 (LMSv5) use AI or machine learning?

Yes. LiverMultiScan v5 (LMSv5) (K213960) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for LiverMultiScan v5 (LMSv5)?

LiverMultiScan v4.0.0 (K202170); R2-MRI Analysis System (FerriScan) (K043271).

Who can help prepare an FDA 510(k) submission like LiverMultiScan v5 (LMSv5)?

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.

Can an AI/ML device like LiverMultiScan v5 (LMSv5) get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

LiverMultiScan v5 (LMSv5)

K213960 · Perspectum · LNH · Sep 6, 2022 · Radiology

Device Facts

Record ID	K213960
Device Name	LiverMultiScan v5 (LMSv5)
Applicant	Perspectum
Product Code	LNH · Radiology
Decision Date	Sep 6, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1000
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

LiverMultiScan v5 (LMSv5) 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. LMSv5 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. LMSv5 provides several 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*, LIC (Liver Iron Concentration) and iron corrected T1 (cT1) measurements. 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

LMSv5 is a standalone post-processing software device for liver evaluation. It ingests DICOM 3.0 MR image datasets from compatible scanners. The device uses machine-learning-based automated liver segmentation and artifact detection to assist operators in placing ROIs on parametric maps. It calculates quantitative metrics: PDFF, T2*, LIC, and cT1. The software generates a summary report for interpretation by a clinician. Used at Perspectum’s image analysis center by trained internal operators. The output assists clinicians in diagnosing and monitoring liver health. It does not replace clinical procedures or provide automated diagnoses; it serves as an aid to clinical decision-making.

Clinical Evidence

Bench testing only. Performance validated via functional verification, phantom testing (accuracy/precision across physiological ranges), and in-vivo volunteer data to assess measurement precision across supported scanners. Inter- and intra-operator variability was evaluated. No clinical trials were required as the device is a post-processing software tool.

Technological Characteristics

Standalone software application; DICOM 3.0 compliant; platform-independent (installed on general-purpose workstations). Employs machine-learning for automated liver segmentation and artifact detection. Quantitative methods include IDEAL (for PDFF) and MOST (for LIC). No energy delivery or patient monitoring. Software level of concern: Moderate.

Indications for Use

Indicated for patients suitable for MRI who are not contraindicated. Used for noninvasive liver evaluation, including quantification of PDFF, T2*, LIC, and cT1 measurements to assist clinicians in diagnosis.

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 v4.0.0 (K202170)
R2-MRI Analysis System (FerriScan) (K043271)

Related Devices

K202170 — LiverMultiScan · Perspectum, Ltd. · Oct 2, 2020
K190017 — LiverMultiScan (LMSv3) · Perspectum Diagnostics, Ltd. · Jun 27, 2019
K253413 — LiverMultiScan (v6.0) · Perspectum, Ltd. · Mar 9, 2026
K172685 — LiverMultiScan · Perspectum Diagnostics, Ltd. · Nov 21, 2017
K203280 — Hepatica v1 (Hepatica v1.0.0) · Perspectum, Ltd. · Jan 12, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. September 6, 2022 Perspectum Ltd. % Ioan Wigley Head of Regulatory Affairs Gemini One 5520 John Smith Drive Oxford, Oxfordshire OX 2LL UNITED KINGDOM Re: K213960 Trade/Device Name: LiverMultiScan v5 (LMSv5) Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: July 26, 2022 Received: July 26, 2022 Dear Ioan Wigley: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, 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 510(k) Number (if known) K213960 Device Name LiverMultiScan v5 #### Indications for Use (Describe) LiverMultiScan v5 (LMSv5) 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. LMSv5 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. LMSv5 provides several 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*, LIC (Liver Iron Concentration) and iron corrected T1 (cT1) measurements. 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) | | |----------------------------------------------------------------------------------|----------------------------------------------------------------------| | <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> 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}------------------------------------------------ # Dect Date Prepared: 01 September 2022 K213960 ## Submitter Details Owner Address: Perspectum Ltd Gemini One, 5520 John Smith Drive, Oxford Business Park, Oxford, OX4 2LL +44 (0) 1865 655329 | Owner/Operator Number: | 10056574 | |------------------------------------|------------------------------------------------------------------| | Establishment Registration Number: | 3014232555 | | Contact Person: | loan Wigley loan.Wigley@perspectum.com +44 (0) 1865 655329 | ## Subject and Predicate Devices | | Subject Device | Primary Predicate Device | Secondary Predicate Device | |----------------------|-----------------------------------------------|-----------------------------------------------|-----------------------------------------------| | 510(k) number | Not known | K202170 | K043271 | | Legal Manufacturer | Perspectum Ltd. | Perspectum Ltd. | Inner Vision Biometrics Pty | | Owner/Owner Operator | 10056574 | 10056574 | / | | Device Name | LiverMultiScan v5.0.0 | LiverMultiScan v4.0.0 | R2-MRI Analysis System (FerriScan) | | Proprietary/Common | LiverMultiScan, LMSv5, LMS | LiverMultiScan, LMSv4, LMS | FerriScan | | Panel | Radiology | Radiology | Radiology | | Regulation | 892.1000 | 892.1000 | 892.1000 | | Risk Class | Class II | Class II | Class II | | Product Class code | LNH | LNH | LNH | | Classification | System, Nuclear Magnetic Resonance Imaging | System, Nuclear Magnetic Resonance Imaging | System, Nuclear Magnetic Resonance Imaging | {4}------------------------------------------------ # Subject Device #### General Description LiverMultiScan v5 (LMSv5) is a standalone software device. The LiverMultiScan v5 device is to assist a trained operator with the evaluation of information from Magnetic Resonance (MR) images from a single time-point (a patient visit). LiverMultiScan is a post-processing software device, a trained operator uses tools within the device interface to quantify liver tissue characteristics from parametric maps. LiverMultiScan v5 includes automatic processing functionality based on machine-learning to assist in the quantification of metrics during analysis, such as automatic artefact detection and automatic segmentation of the liver. A summary report from the analysis conducted is generated for interpretation by a clinician. LiverMultiScan v5 is not intended to replace the established procedures for the assessment of a patient's liver health by a clinician, providing many opportunities for competent human intervention in the clinical care of patients. The metrics are intended to be used as an additional diagnostic input to provide information to clinicians as part of a wider diagnostic process. It is expected that in the normal course of clinical care, patients with clinical symptoms or risk factors which may indicate liver disease. The interpreting clinician needs to take into consideration the device's limitations and accuracy during clinical interpretation. Information gathered through existing diagnostic tests and clinical evaluation of the patient, as well as information obtained from LiverMultiScan v5 metrics, may contribute to a diagnostic decision. LiverMultiScan v5 is not a computer-aided diagnostic device and can only present imaging information which must be interpreted by a qualified clinician. LiverMultiScan v5 is an aid to diagnosis and treatment decisions remain the responsibility of the clinician. #### Intended Use and Indications for Use LiverMultiScan v5 (LMSv5) 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. LMSv5 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. LMSv5 provides several 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*, LlC (Liver Iron Concentration) and iron corrected T1 (cT1) measurements. These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis. #### Indications and contraindications LiverMultiScan is indicated for use where MRI is not contraindicated. #### Contraindications LiverMultiScan is indicated for use where MRI is not contraindicated. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the word "Perspectum" in a dark gray sans-serif font. To the right of the word is a circular logo divided into four colored sections: yellow, blue, green, and pink. The logo has a small "R" in a circle in the upper right corner. #### Intended Conditions LiverMultiScan is not intended to be used for use on any specific disease or condition, but the information provided in the report, when interpreted by a licensed physician, may benefit the clinical management, including diagnosis and monitoring of patients. #### Standalone Software LiverMultiScan is a post-processing software device. All operations are directly controlled by the LiverMultiScan device. LiverMultiScan does not control other firmware or software outside of the device {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the word "Perspectum" in a dark gray sans-serif font. To the right of the word is a circular logo that is divided into four colored sections: yellow, blue, green, and pink. The logo also has a small "registered trademark" symbol in the upper right corner. ### Subject and Predicate Comparison The following characteristics were compared between the predicate device in order to demonstrate substantial equivalence. | Characteristi c | LMSv5 (Subject device) | LMSv4 (Primary Predicate Device) | R2-MRI Analysis System (FerriScan) (Secondary Predicate) | |--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | LiverMultiScan v5 (LMSv5) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times. LMSv5 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 (LMSv4) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times. LiverMultiScan (LMSv4) 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. | For the analysis of multi- slice, spin-echo MRI data sets of the liver for the measurement of liver R2 and liver iron concentration. | | Characteristi c | LMSv5 (Subject device) | LMSv4 (Primary Predicate Device) | R2-MRI Analysis System (FerriScan) (Secondary Predicate) | | | LMSv5 provides several 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*, LIC (Liver Iron Concentration) and iron corrected T1 (cT1) measurements. | LiverMultiScan (LMSv4) 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 assessments of selected regions include the determination of triglyceride fat fraction in the liver (PDFF), T2* and iron-corrected T1 (cT1) measurements. T2* may be optionally computed using the DIXON or LMS MOST methods. | | | | These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis. | These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis. | | | Indications for Use | Same as intended use | Same as intended use | The R2-MRI Analysis System is an accessory diagnostic device to MRI scanners and is intended for diagnostic use to present images that reflect the magnetic resonance spectra for the determination of iron on the liver. | | Characteristi c | LMSv5 (Subject device) | LMSv4 (Primary Predicate Device) | R2-MRI Analysis System (FerriScan) (Secondary Predicate) | | Target Population | Patients suitable to undergo an MRI scan and not contra-indicated for MRI | Patients suitable to undergo an MRI scan and not contra-indicated for MRI | Patients suitable to undergo an MRI scan and not contra- indicated for MRI | | Device User | Trained Perspectum internal operator | Trained Perspectum internal operator | Resonance Health's trained analyst | | Report User | An interpreting clinician or healthcare practitioner | An interpreting clinician or healthcare practitioner | An interpreting clinician or healthcare practitioner | | Device Use Environment | Installation of LiverMultiScan v5 is controlled and is installed on general purpose workstations that meet the minimum technical requirements at Perspectum's image analysis centre by specialist members of staff. | Installation of LMSv4 is controlled and is installed on general purpose workstations that meet the minimum technical requirements at Perspectum's image analysis centre by specialist members of staff. | Image analysis and LIC reporting is performed at a central ISO 13485 certified Service Centre. Hosting platform is resonance health's internal server. | | Clinical Setting | LiverMultiScan v5 is a standalone post-processing software device that is intended to be installed on general use workstations at Perspectum's image analysis centre. Operators use LMSv5 to conduct quantitative analysis of liver tissue characteristics to produce a report. The end-users for the output from the device, the report, are clinicians who receive and interpret LiverMultiScan (LMSv5) reports. | LMSv4 is a standalone post- processing software device that is intended to be installed on general use workstations at Perspectum's image analysis centre. Operators use LMS to conduct quantitative analysis of liver tissue characteristics to produce a report. The end-users for the output from the device, the report, are clinicians who receive and interpret LMSv4 reports. | FerriScan is a standalone software tool that is intended to be used by Resonance Health's trained analyst, FerriScan is installed and runs on the Resonance Health's internal server. The report result is overseen by the radiologist and the final decision for clinical management of the patient is made by their treating clinician. | | Anatomical Location | Abdomen, including the liver | Abdomen, including the Liver | Abdomen, including the Liver. | | Characteristi c | LMSv5 (Subject device) | LMSv4 (Primary Predicate Device) | R2-MRI Analysis System (FerriScan) (Secondary Predicate) | | Energy | LiverMultiScan v5 is a standalone software application, it does not deliver, monitor or depend on energy delivered to or from patients. | LMS is a standalone software application, it does not deliver, monitor or depend on energy delivered to or from patients. | FerriScan is a standalone software application. It does not deliver, monitor or depend on energy delivered to or from patients. | | Design: Purpose | LiverMultiScan v5 is a standalone software application that imports MR data sets encompassing the abdomen, including the liver. Visualisation and display of 2D multi-slice, spin-echo MR data can be analysed and quantitative metrics of tissue characteristics are then reported. Datasets imported into LiverMultiScan (LMSv5) are DICOM 3.0 compliant, reported metrics are independent of the MRI equipment vendor. | LMS is a standalone software application that imports MR data sets encompassing the abdomen, including the liver. Visualisation and display of 2D multi-slice, spin-echo MR data can be analysed and quantitative metrics of tissue characteristics are then reported. Datasets imported into LMS are DICOM 3.0 compliant, reported metrics are independent of the MRI equipment vendor. | FerriScan is intended for: • Supporting clinical diagnoses about the status of liver iron concentration. • Supporting the subsequent clinical decision-making processes. • Supporting the use in clinical research trials, directed at studying changes in liver iron concentration as a result of interventions. • It contains an image viewer for importing DICOM images, browsing through patient datasets, viewing images and performing region of interest analysis | | Characteristi | LMSv5 (Subject device) | LMSv4 (Primary Predicate Device) | R2-MRI Analysis System | | c | | | (FerriScan) (Secondary Predicate) | | Design: Tools | Allows for the visualisation via parametric maps and quantification of metrics (cT1, LIC and PDFF) from liver tissue and exportation of results & images to a deliverable report. | Allows for the visualisation via parametric maps and quantification of metrics (cT1, T2* and PDFF) from liver tissue and exportation of results & images to a deliverable report. | Allows for the visualisation of images that reflect the magnetic resonance spectra for the determination of iron on the liver. It contains | | | Quantification is through either full segmentation of the outer liver contour and liver vasculature or manual placement of ROI's on the parametric maps. IQR and median metrics are reported from the segmentation/ROI quantification. automatically detects artefacts on the and are delineated on the parametric map computed images as well as recommends slices to be used as the | Quantification is through either full segmentation of the outer liver contour and liver vasculature or manual placement of ROI's on the parametric maps. IQR and median metrics are reported from the segmentation/ROI quantification. | an image viewer for • importing DICOM images, • browsing through patient datasets, • viewing images and performing ROI analysis. | | Design: MR Relaxometry | quantitative output of the device. T1, iron corrected T1 (cT1) mapping and LIC | T1, iron corrected T1 (cT1) and T2* mapping | R2 (Signal Decay Rate) mapping | | Design: Liver Fat Quantificatio n | Utilizes MR images that exploit the difference in resonance frequencies between hydrogen nuclei in water and triglyceride fat using the LiverMultiScan v5 IDEAL method. | Utilizes MR images that exploit the difference in resonance frequencies between hydrogen nuclei in water and triglyceride fat using the LMS IDEAL method. | N/A | | Design: Parametric Maps | Iron corrected T1 (cT1), Proton Density Fat Fraction (PDFF) and LIC parametric maps can be created from all supported scanners. | Iron corrected T1 (cT1), T2* and Proton Density Fat Fraction (PDFF) parametric maps can be created from all supported scanners. | FerriScan calculates the signal decay rate (R2) that is used to characterise iron loading in the liver. It produces an output report | | Characteristic | LMSv5 (Subject device) | LMSv4 (Primary Predicate Device) | R2-MRI Analysis System (FerriScan) (Secondary Predicate) | | | It is possible to use the LIC maps and knowledge of the measurements and the scanner field strength to correct for signal changes related to iron deposits, producing a cT1 map. The cT1 map eliminates the effects of elevated iron from the T1 measurement (3) and standardizes for the fat signal across scanner manufacturers. PDFF is quantified using the LMS IDEAL method. Parametric maps of LIC are quantified using the LMS MOST method. LMSv5 uses the measured T2* value and uses them to characterise iron loading in the liver which is then transformed by a defined calibration curve to provide a quantitative measure of liver iron concentration in vivo. LMSv5 presents images that reflect the magnetic resonance spectra for iron determination on the liver. | It is possible to use the T2* and PDFF maps and knowledge of the T2* and PDFF measurements and the scanner field strength to correct for signal changes related to iron deposits, producing a cT1 map. The cT1 map eliminates the effects of elevated iron from the T1 measurement (3) and standardizes for the fat signal across scanner manufacturers. PDFF is quantified using the LMS IDEAL method. Parametric maps of T2* may optionally be computed using either the three-point DIXON method or the LMS MOST method. | comprising R2 which is transformed by a defined calibration curve into a quantitative measure of liver iron concentration in vivo. FerriScan presents images that reflect the magnetic resonance spectra for iron determination on the liver. | | Design: Visualisation | Numerous views within the LiverMultiScan v5 interface can be used to assist in analysis of Iron corrected T1 (cT1), triglyceride fat (also known as Proton Density Fat Fraction (PDFF)) and LIC parametric | Numerous views within the LMSv4 interface can be used to assist in analysis, Iron-corrected T1 (cT1), T2* and triglyceride fat (also known as Proton Density Fat Fraction (PDFF)) parametric maps can be created from | Visualisation of multi-slice, spin-echo MRI data sets encompassing the abdomen. Software tool calculates the signal decay rate (R2) that is | | Characteristi c | LMSv5 (Subject device) | LMSv4 (Primary Predicate Device) | R2-MRI Analysis System (FerriScan) (Secondary Predicate) | | | maps can be created from all supported scanners. Parametric maps displayed using the LMSv5 colourmap, designed to have maximum contrast on liver parenchymal tissue. | all supported scanners. R2 maps can also be utilised to assess the quality of the map fitting. Iron- corrected T1 (cT1) displayed using LMSv4 colourmap, designed to have maximum contrast on liver parenchymal tissue. | used to characterise iron loading in the liver, which is then transformed by a defined calibration curve to provide a quantitative measure of liver iron concentration in vivo. LIC is displayed on a map and histogram within the FerriScan LIC report. | | Design: Supported Modalities | DICOM 3.0 compliant MR data from | DICOM 3.0 compliant MR data from | DICOM Image Format. Functionality independent of MRI equipment vendor. | | | supported MRI scanners. | supported MRI scanners. | | {7}------------------------------------------------ Image /page/7/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. The logo is divided into four quadrants, each with a different color: yellow, blue, green, and pink. {8}------------------------------------------------ Image /page/8/Picture/1 description: The image is a logo for Perspectum. The word "Perspectum" is written in a bold, sans-serif font in dark gray. To the right of the word is a circular graphic with four different colored sections: yellow, blue, green, and pink. There is a registered trademark symbol in the upper right corner of the graphic. {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the word "Perspectum" in a bold, sans-serif font. To the right of the word is a circular logo that is divided into four colored sections: yellow, blue, green, and pink. The logo also has a small "R" in a circle in the upper right corner. {10}------------------------------------------------ Image /page/10/Picture/1 description: The image shows the word "Perspectum" in a bold, dark gray font. To the right of the word is a colorful circular logo. The logo is divided into four quadrants, with each quadrant a different color: yellow, blue, green, and pink. There is a registered trademark symbol in the upper right corner of the logo. {11}------------------------------------------------ Image /page/11/Picture/1 description: The image shows the word "Perspectum" in a dark gray sans-serif font. To the right of the word is a circular logo that is divided into four colored sections: yellow, blue, green, and pink. There is a registered trademark symbol next to the logo. {12}------------------------------------------------ Image /page/12/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 divided into four colored sections: yellow, blue, green, and pink. A small registered trademark symbol is located in the upper right corner of the logo. {13}------------------------------------------------ ## Differences between subject and predicate devices - The LMSv5 device offers additional quantification tools in its interface that are not available in the primary . predicate device, LMSv4. LMSv5 automatically detects artefacts on the and are delineated on the parametric map computed images as well as recommends slices to be used as the quantitative output of the device. Artefact areas are overlayed on the parametric maps to assist in quantification and interpretation. -…