LMS is indicated for use as 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.

LMS is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from Siemens MAGNETOM Skyra MR Scanners, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced.

LMS provides a number of quantification tools such as rulers and region of interest to be used for the assessment of regions of an image to support existing clinical workflows.

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

Device Description

LiverMultiScan (LMS) is a standalone software application for displaying 2D Magnetic Resonance medical image data acquired from Siemens MAGNETOM Skyra MR Scanners. LMS runs on a workstation with color monitor, keyboard and mouse.

LMS is designed to allow the review of DICOM 3.0 compliant datasets stored on the workstation and the user may also create, display, print, store and distribute reports resulting from interpretation of the datasets.

LMS allows the display and comparison of combinations of magnetic resonance images and provides a number of tools for the quantification of magnetic resonance images, including the determination of triglyceride fat fraction in the liver.

LMS provides a number of tools such as rulers and circular region of interest to be used for the assessment of regions of an image to support a clinical workflow.

LMS allows users to create relaxometry parameter maps of the abdomen which can be used by clinicians to help determine different tissue characteristics to support a clinical workflow. Examples of such workflows include, but are not limited to, the evaluation of the presence or absence of liver fat.

LiverMultiScan (LMS) is intended to be used by trained healthcare professionals including, but not limited to, radiologists, gastroenterologists, radiographers and physicists.

LiverMultiScan is an aid to diagnosis. When interpreted by a trained physician, the results provide information, which may be used as an input into existing clinical procedures and diagnostic workflows.

LiverMultiScan offers:

. Advanced visualization of MR data
. Processing of MR data to quantify tissue characteristics including MR Relaxivity constants such as T2*, T1. cT1 and liver fat percentage
. Circular Region of interest statistics
Snapshot of images to include in a report
Report to include region statistics, snapshot images and user-entered text
Export of snapshot images and report to storage
. Integration with Mirada DBx – a software module that maintains a local temporary cache of DICOM data and can interact with PACS, from which it can receive data

Mirada DBx is a medical device data system (MDDS, product code OUG, regulation number 880.6310) used for DICOM connectivity with other systems.

Ability to send data from Mirada DBx to PACS or other DICOM nodes for archive and distribution

AI/ML Overview

The provided documents (FDA 510(k) summary and letters for LiverMultiScan) describe the device and its intended use, and generally state that it has been validated and verified. They assert that LiverMultiScan is substantially equivalent to the predicate device, Siemens syngo MR E11A software, for both safety and effectiveness.

However, the provided text does not include specific acceptance criteria, detailed study results, or quantitative performance metrics that would allow for a comprehensive breakdown as requested. The document focuses on regulatory compliance and comparison to a predicate device, rather than providing the granular technical study details.

Here's a breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

Missing. The document generally states that "performance, functional and algorithmic testing demonstrate that LiverMultiScan meets the user needs and requirements of the device," and "performs at least as safely and effectively as the listed predicate device." However, no specific acceptance criteria (e.g., minimum accuracy, sensitivity, specificity, or error rates) or reported device performance values are provided.

2. Sample size used for the test set and the data provenance

Missing. The documents mention "validated with volunteer and phantom scans" for performance but do not specify the sample size for any test set or the provenance (country of origin, retrospective/prospective nature) of the data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Missing. The documents mention that images and parameters should be "interpreted by a trained physician" but do not specify the number or qualifications of experts used to establish ground truth for testing.

4. Adjudication method for the test set

Missing. No adjudication method (e.g., 2+1, 3+1, none) for a test set is described.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size

Missing. The document does not describe a multi-reader, multi-case comparative effectiveness study, nor does it quantify any effect size of AI assistance on human readers. The comparison is primarily at the device level, concluding substantial equivalence based on intended use and technical characteristics.

6. If a standalone (algorithm only without human-in-the-loop performance) was done

Implied, but details are missing. LiverMultiScan is described as a "standalone software application." The validation mentions "algorithmic testing," suggesting standalone performance testing, but no specific results or study design for this are provided. The "intended use" explicitly states that the results, "when interpreted by a trained physician, yield information that may assist in diagnosis," indicating that the device is intended to be used with human-in-the-loop.

7. The type of ground truth used

Partially available, but vague. The document mentions "validated with volunteer and phantom scans." This implies that physical phantoms with known properties were used for part of the validation, and "volunteer" scans suggest potentially healthy subjects or subjects with characterized conditions. However, the exact nature of the "ground truth" (e.g., expert consensus, pathology, outcome data) for the volunteer scans or for clinical validation is not specified.

8. The sample size for the training set

Missing. The documents do not provide any information about the training set size, or even explicitly state that a machine learning model requiring a training set is part of the device (though "algorithmic testing" might imply this).

9. How the ground truth for the training set was established

Missing. As the training set size and existence are not described, the method for establishing its ground truth is also not mentioned.

Summary of what is available from the document:

Device Name: LiverMultiScan (LMS)
Intended Use: Non-invasive liver evaluation by generating, displaying, and reviewing 2D MR medical image data and pixel maps for MR relaxation times from Siemens MAGNETOM Skyra MR Scanners. Provides quantification tools (rulers, ROI) and physical parameters (like triglyceride fat fraction, T1, cT1, T2* mapping) for interpretation by a trained physician to assist in diagnosis.
Regulatory Class: Class II (892.1000) Product Code: LNH
Predicate Device: Software syngo MR E11A for the MAGNETOM systems Aera/Skyra (Siemens AG, 510(k) K141977)
Basis for Equivalence: Substantial equivalence based on similar intended use, technological characteristics (e.g., utilizing DICOM 3.0 compliant MR datasets, supporting multi-slice MR data, providing quantification tools like ROI measurements, generating reports), and performance validated with volunteer and phantom scans.
Standards Met: IEC 62304, DICOM 3.0
Compatibility: Compatible with data from Siemens Skyra 3T MR scanners and Microsoft Windows.
Validation Statement: "LiverMultiScan is validated and verified against its user needs and intended use by the successful execution of planned performance, functional and algorithmic testing included in this submission."

The provided document serves as a regulatory submission focused on demonstrating substantial equivalence rather than a detailed technical study report. Therefore, it lacks the specific quantitative data points typically found in clinical validation studies.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 23, 2015

Mirada Medical, Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K143020

Trade/Device Name: LiverMultiScan Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: June 9, 2015 Received: June 10, 2015

Dear Mr. Job:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For

Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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FDA Indications for Use Form

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K143020 Device Name

LiverMultiScan

Indications for Use (Describe)

[LMS is indicated for use as 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.

LMS provides a number of quantification tools such as rulers and region of interest to be used for the assessment of regions of an image to support existing clinical workflows.

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

Type of Use (Select one or both, as applicable)	[X] Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
-------------------------------------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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LiverMultiScan 510(k) Summary

Date of summary:	10 May 2015
Submitter's name:	Mirada Medical Ltd
Submitter's address:	Oxford Centre for InnovationNew RoadOxfordOxfordshireOX1 1BYUnited Kingdom
Submitter's contact:	Gwilym Owen
Telephone number:	+44 (0)1865 261410
Device Proprietary Name:	LiverMultiScan
Device Common Name(s):	LiverMultiScan, LMS
Classification Name:	Class II: Magnetic Resonance Imaging System
	(892.1000) Product Code: LNH

LiverMultiScan is Substantially Equivalent to the following Legally Marketed devices:

Predicate Devices

510(k) Number	Trade Name	Manufacturer
K141977	Software syngo MR E11A for theMAGNETOM systems Aera/Skyra	Siemens AG

Intended Use

LMS is indicated for use as magnetic resonance diagnostic device standalone 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.

LMS is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced.

LMS provides a number of quantification tools such as rulers and region of interest to be used for the assessment of regions of an image to support existing clinical workflows.

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

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Device Description

LMS provides a number of tools such as rulers and circular region of interest to be used for the assessment of regions of an image to support a clinical workflow.

LiverMultiScan (LMS) is intended to be used by trained healthcare professionals including, but not limited to, radiologists, gastroenterologists, radiographers and physicists.

LiverMultiScan offers:

. Advanced visualization of MR data
. Processing of MR data to quantify tissue characteristics including MR Relaxivity constants such as T2*, T1. cT1 and liver fat percentage
. Circular Region of interest statistics
Snapshot of images to include in a report
Report to include region statistics, snapshot images and user-entered text
Export of snapshot images and report to storage
. Integration with Mirada DBx – a software module that maintains a local temporary cache of DICOM data and can interact with PACS, from which it can receive data

Mirada DBx is a medical device data system (MDDS, product code OUG, regulation number 880.6310) used for DICOM connectivity with other systems.

Ability to send data from Mirada DBx to PACS or other DICOM nodes for archive and distribution

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Testing

LiverMultiScan is validated and verified against its user needs and intended use by the successful execution of planned performance, functional and algorithmic testing included in this submission. The results of performance, functional and algorithmic testing demonstrate that LiverMultiScan meets the user needs and requirements of the device, which are demonstrated to be substantially equivalent to those of the listed predicate devices.

Verification and Validation for LiverMultiScan has been carried out in compliance with the requirements of ISO 13485:2003, CFR 21 Part 820 and in adherence to the DICOM standard.

In conclusion, performance testing demonstrates that LiverMultiScan is substantially equivalent to, and performs at least as safely and effectively as the listed predicate device. LiverMultiScan meets requirements for safety and effectiveness and does not introduce any new potential safety risks.

Comparison to Predicate Devices

The proposed device is substantially equivalent to the predicate device image processing applications.

Although the proposed device does not contain software for image acquisition, the proposed device and predicate device support multi-slice MR data acquired using the same specific acquisition protocols, from the same scanner type and acquisition software to acquire the input data.

The proposed and predicate device include software applications which utilize MR data to visualize and enable quantify physiological characteristics in the liver to provide measurements which may be used to aid diagnosis.

The proposed device and both predicate device are software applications to facilitate the import and visualization of MR data sets.

Both the proposed device and the predicate device include applications to facilitate the import and visualization of MR data sets and include tools to enable the manipulation of the views and to enable the quantification and analysis of tissue characteristics in the liver from the MR data.

The proposed device and the predicate enable the quantification of analysis of tissue characteristics in the liver from the MR data.

The proposed device and the predicate device both support region of interest measurements derived from MR images and parametric maps of tissue characteristics.

The proposed device and predicate device facilitate the creation of a medical report containing the images and data analysis derived from quantification of liver tissue parameters.

The proposed device and predicate device reports all include tabular display of quantification statistics, parametric map images and include normal range references.

In conclusion, the proposed device (LiverMultiScan) does not result in any new potential safety risk and performs in accordance with its intended use as well as comparatively with the intended use of the chosen predicate.

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We conclude that the LiverMultiScan device is as safe and effective as the predicate devices and poses no unanswered questions with regard to safety and efficacy.

The key similarities and differences are highlighted in the following summary table.

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Device Comparison Table

Characteristic	LiverMultiScan	Software syngo MR E11A for the MAGNETOM systems Aera/Skyra
510(k) number	Not known	K141977
Classification	Class II. 892.1000 LNH	Class II. 892.1000 LNH
Intended Use	LMS is indicated for use as magnetic resonance diagnosticdevice software application for non-invasive liver evaluationthat enables the generation, display and review of 2D magneticresonance medical image data and pixel maps for MR relaxationtimes.	The MAGNETOM systems [MAGNETOM Aera and MAGNETOM Skyra] areindicated for use as a magnetic resonance diagnostic device (MRDD) thatproduces transverse, sagittal, coronal and oblique cross sectional images,spectroscopic images and/or spectra, and that displays the internal structureand/or function of the head, body, or extremities.
	LMS is designed to utilize DICOM 3.0 compliant magneticresonance image datasets, acquired from Siemens MAGNETOMSkyra MR Scanners, to display the internal structure of theabdomen including the liver. Other physical parameters derivedfrom the images may also be produced.	Other physical parameters derived from the images and/or spectra may also be produced.Depending on the region of interest, contrast agents may be used. These imagesand/or spectra and the physical parameters derived from the images and/orspectra, when interpreted by a trained physician, yield information that mayassist in diagnosis.The MAGNETOM systems may also be used for imaging during interventionalprocedures when performed with MR compatible devices such as in-room displayand MR-Safe biopsy needles.
	LMS provides a number of quantification tools such as rulersand region of interest to be used for the assessment of regionsof an image to support existing clinical workflows.These images and the physical parameters derived from theimages, when interpreted by a trained physician, yieldinformation that may assist in diagnosis.
DeviceDescription	LMS is a standalone software application for displaying 2DMagnetic Resonance medical image data acquired fromSiemens MAGNETOM Skyra MR Scanners. LMS runs on a	The subject device, software syngo MR E11A for MAGNETOM Aera andMAGNETOM Skyra offers two new applications, LiverLab (an application of non-invasive liver evaluation) and MyoMaps (an application designed to provide ameans to generate pixel maps for myocardial MR relaxation times). In addition,
software syngo MR E11A makes the Dot Cockpit available for the user to modifyworkstation with color monitor, keyboard and mouse.and create Siemens Dot Engine workflows in a very intuitive way whichLMS is designed to allow the review of DICOM 3.0 compliantMR E11A also includes new and modified sequences as well as minordatasets stored on the workstation and the user may alsomodifications of already existing features. In addition, three additional coils arecreate, display, print, store and distribute reports resulting frominterpretation of the datasets.offered and some hardware components have been modified.Siemens Medical Solutions, USA Inc., intends to market MAGNETOM Aera andLMS allows the display and comparison of combinations ofMAGNETOM Skyra with new software, syngo MR E11A. While syngo MR E11Amagnetic resonance images and provides a number of tools foroffers additional capabilities with respect to the predicate device, thethe quantification of magnetic resonance images, including theMAGNETOM Aera and MAGNETOM Skyra have the same technologicaldetermination of triglyceride fat fraction in the liver.characteristics as the predicate device (K121434; Cleared November, 5, 2012).LMS provides a number of tools such as rulers and circularFurthermore, Siemens Medical Solutions, USA Inc., intends to market a newregion of interest to be used for the assessment of regions of anconfiguration of the MAGNETOM Skyra with 24 receive channels with softwareimage to support a clinical workflow.syngo MR E11A.LMS allows users to create relaxometry parameter maps of theThe MAGNETOM Aera and MAGNETOM Skyra will be offered ex-factory (newabdomen which can be used by clinicians to help determineproduction) as well as in-field upgrades for the currently installed MAGNETOMdifferent tissue characteristics to support a clinical workflow.Aera and MAGNETOM Skyra systems. The new MAGNETOM Skyra configurationExamples of such workflows include, but are not limited to, thewith 24 receive channels will be offered as an ex-factory option (newevaluation of the presence or absence of liver fat.production).The MAGNETOM systems [MAGNETOM Aera and MAGNETOM Skyra] areIndications forLMS is indicated for use as magnetic resonance diagnosticdevice software application for non-invasive liver evaluationindicated for use as a magnetic resonance diagnostic device (MRDD) thatUsethat enables the generation, display and review of 2D magneticproduces transverse, sagittal, coronal and oblique cross sectional images,resonance medical image data and pixel maps for MR relaxationspectroscopic images and/or spectra, and that displays the internal structureand/or function of the head, body, or extremities.times.	Characteristic	LiverMultiScan	Software syngo MR E11A for the MAGNETOM systems Aera/Skyra

			supplements some of the support of an application specialist. The software syngo




LMS is designed to utilize DICOM 3.0 compliant magneticOther physical parameters derived from the images and/or spectra may also be
Characteristic	LiverMultiScan	Software syngo MR E11A for the MAGNETOM systems Aera/Skyra
	resonance image datasets, acquired from Siemens MAGNETOMSkyra MR Scanners, to display the internal structure of theabdomen including the liver. Other physical parameters derivedfrom the images may also be produced.	produced.
	LMS provides a number of quantification tools such as rulersand region of interest to be used for the assessment of regionsof an image to support existing clinical workflows.	Depending on the region of interest, contrast agents may be used. These imagesand/or spectra and the physical parameters derived from the images and/orspectra, when interpreted by a trained physician, yield information that mayassist in diagnosis.
	These images and the physical parameters derived from theimages, when interpreted by a trained physician, yieldinformation that may assist in diagnosis.	The MAGNETOM systems may also be used for imaging during interventionalprocedures when performed with MR compatible devices such as in-room displayand MR-Safe biopsy needles.
Target Population	Any patient type who is suitable for an MRI scan	Any patient type who is suitable for an MRI scan
Where used	Clinical/Hospital Environment	Clinical/Hospital Environment
Anatomical Site	Abdomen, Liver	Abdomen, Liver, Heart, various other anatomical sites
Energy Usedand/or Delivered	None – software only application. The software applicationdoes not deliver or depend on energy delivered to or frompatients	When used in conjunction with MAGNETOM MR Scanners, the scanner deliverselectromagnetic energy. The software applications do not deliver or depend onenergy delivered to or from patients
Human factors	Designed to be used by trained clinicians	Designed to be used by trained clinicians
Design Purpose	Standalone software application to facilitate the import andvisualization of MR data sets encompassing the abdomen,including the liver with functionality independent of the MRIequipment vendor	Software tool used as an accessory to an MR scanning machine, to facilitate theimport and visualization of multi-slice, spin-echo MR data sets. Includes anapplication for visualization of Cardiac MR datasets and an application for MRdatasets encompassing the abdomen for visualization of the Liver
Design: Datavisualization	Software application intended to display and visualize 2D multi-slice, spin-echo MR data sets encompassing the abdomen. Theuser may process, and review DICOM 3.0 compliant datasetswithin the system and/or across computer networks	software application for visualization of DICOM 3.0 compliant multi-slice, spin-echo MR data sets encompassing the abdomen and chest
Design: MRrelaxometry	T1, cT1 & T2* Mapping	T1, T2 & T2* Mapping
Characteristic	LiverMultiScan	Software syngo MR E11A for the MAGNETOM systems Aera/Skyra
mapping
Design: Liver Fatquantification	Utilizes magnetic resonance images that exploit the differencein resonance frequencies between hydrogen nuclei in waterand triglyceride fat using DIXON method	Utilizes magnetic resonance images that exploit the difference in resonancefrequencies between hydrogen nuclei in water and triglyceride fat using DIXONmethod
Design: Region ofInterestmeasurements	Mean, Median, Standard deviation, Interquartile rangemeasurements created from a cross sectional slice of livertissue	Mean, Standard deviation, Histogram.
Design:Supportedmodalities	DICOM 3.0 compliant MR data from GRE Echo & Molliacquisition protocols.	DICOM 3.0 compliant MR data from GRE Echo & Molli acquisition protocols.
Design: Reporting	Liver quantification images and analysis collated in a report.	Liver quantification images and analysis collated in a report. Cardiacquantification images and analysis collated in a report
Performance	Validated with volunteer and phantom scans	Validated with volunteer and phantom scans and synthetic raw data
Standards met	IEC 62304, DICOM 3.0	IEC 62304, DICOM 3.0
Materials	Software product only	Not applicable to software component of this device.
Biocompatibility	N/A, Software product only	N/A, Not applicable to software component of this device.
Compatibilitywith the	Compatible with data from Siemens Skyra 3T MR scanners.	Compatible with data from Siemens Aera 1.5T & Skyra 3T MR scanners
environment andother devices	Compatible with Microsoft windows	Compatible with Microsoft windows
Sterility	N/A, Software product only	Not applicable to software component of this device.
Electrical Safety	N/A, Software product only	Not applicable to software component of this device.
MechanicalSafety	N/A, Software product only	Not applicable to software component of this device.
Chemical Safety	N/A, Software product only	Not applicable to software component of this device.
Thermal Safety	N/A, Software product only	Not applicable to software component of this device.
Radiation Safety	N/A, Software product only	Not applicable to software component of this device.
Operating System	Microsoft Windows	Microsoft Windows

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Conclusion

We conclude that the LiverMultiScan device is as safe and effective as the predicate devices and poses no unanswered questions with regard to safety and efficacy.

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
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).(b)
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.