InterView XP is a Software as Medical Device (SaMD) aimed at reviewing medical images such as planar scans (Static, Whole Body, Dynamic, Multi-Gated) and tomographic scans (SPECT, Gated SPECT) acquired by gamma cameras. Review of other image modalities is also supported. Common Users for clinical purposes are trained medical professionals, including clinicians and technicians in hospitals or imaging centers. Software components provide functions for image display, manipulation, enhancements, analysis and quantification. This device is not indicated for mammography use or dental diagnostics. The software provides diagnostic information, however, diagnostic decision cannot be based solely on the software. InterView XP has no specific target population.

InterView FUSION is a Software as Medical Device (SaMD) aimed at reviewing medical images such as planar scans and tomographic scans from SPECT, PET, CT, and MRI modalities. Review of other image modalities is also supported. The common users for clinical purposes are trained medical professionals, including clinicians in hospitals or imaging centers. Software components provide functions for image display, manipulation, enhancements, analysis, and quantification. This device is not indicated for mammography use or dental diagnostics. The software provides diagnostic information - however, diagnostic decisions cannot be based solely on this software. InterView FUSION has no specific target population.

Device Description

InterView XP is a DICOM image visualization and post-processing Software as Medical Device (SaMD). It is a standalone medical device. Developed by Medical Imaging Systems, built on state-of-the-art technologies, providing evaluation method according to the international guidelines for planar, whole body and SPECT nuclear medicine applications. The product is designed as a software only product, operating on Windows based OS. The software inputs are images of nuclear medicine studies that are DICOM 3.0 compatible and uploaded into the user's computer and the Software will process the images in multiple ways to achieve the image analysis by the user's demands.

InterView FUSION is a multi-modal visualization and evaluation software. Developed by Mediso built on state-of-the-art technologies, novel image processing algorithms and tools for evaluating different medical imaging modalities. The product is designed as a standalone software, i.e. Software as Medical Device (SaMD) product, operating on Windows OS as a classical user application.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the InterView XP and InterView FUSION devices, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

The FDA 510(k) summary provided does not explicitly list specific numerical "acceptance criteria" for performance metrics (e.g., sensitivity, specificity, accuracy) of the InterView XP and InterView FUSION software. Instead, the submission relies on demonstrating substantial equivalence to a predicate device (Xeleris V Processing and Review Systems cleared under K201103) based on functional equivalency, technological characteristics, and conformance to relevant standards.

The "reported device performance" is essentially the demonstrated functional capabilities and features of the InterView XP and InterView FUSION, which are compared to the predicate device's functionalities. The study's conclusion is that both devices meet the acceptance criteria for substantial equivalence to the predicate device.

Given the information, a table of acceptance criteria and reported device performance would look like this:

Acceptance Criteria (Implied by Substantial Equivalence to Predicate)	Reported Device Performance (as demonstrated by comparison)
Functional Equivalence
- Medical image display, manipulation, enhancement, analysis, quantification.	The device provides functions for image display, manipulation, enhancements, analysis, and quantification.
- Review of planar scans (Static, Whole Body, Dynamic, Multi-Gated), tomographic scans (SPECT, Gated SPECT).	InterView XP supports these scan types.
- Review of planar scans and tomographic scans from SPECT, PET, CT, and MRI modalities (for FUSION).	InterView FUSION supports these scan types.
- Support for various clinical procedures in Nuclear Medicine (Cardiology, Endocrinology, Osteology, etc. similar to predicate).	Both InterView XP and FUSION support a comprehensive set of nuclear medicine clinical procedures, largely comparable to the predicate. Minor differences in specific processing methods were noted but not deemed to impact substantial equivalence.
- Not for mammography or dental diagnostics.	The device explicitly states it is not for mammography use or dental diagnostics.
- Diagnostic decisions not based solely on the software.	The device explicitly states diagnostic decisions cannot be based solely on the software.
Technological Characteristics
- Standalone Software as Medical Device (SaMD) with Graphical User Interface (GUI).	The device is a standalone SaMD with a GUI.
- Operates on Windows OS (single-user or multi-user environment).	The device operates on Windows 10 (client) or Windows Server 2019 (server).
- DICOM 3.0 compatible.	The device inputs are DICOM 3.0 compatible images.
- Conformance to applicable software and medical device standards.	Non-clinical testing demonstrated conformance to IEC 62304, IEC 62366-1, ISO 12052, NEMA PS3, and FDA guidance on software validation.

1. Sample sized used for the test set and the data provenance:

Test Set Sample Size: Not specified. The submission states that functional design validations and usability validations were performed, and acceptance criteria were fulfilled, implying a test set was used for these validations. However, the exact number of cases or data points in these test sets is not provided in the summary.
Data Provenance: Not specified. The submission does not mention the country of origin of the data or whether it was retrospective or prospective. It only states that the software inputs are "images of nuclear medicine studies that are DICOM 3.0 compatible."

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

This information is not provided in the 510(k) summary. Given that no clinical testing was performed, and the assessment was primarily non-clinical software validation and comparison to a predicate, the "ground truth" as typically understood in clinical efficacy studies with expert review is likely not applicable in the same way. The ground truth for software validation would be adherence to specified requirements and expected outputs.

3. Adjudication method for the test set:

This information is not provided in the 510(k) summary. Since clinical testing with human readers and adjudication for diagnostic performance was not conducted, a formal adjudication method as found in clinical trials would not be present.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC comparative effectiveness study was done. The submission explicitly states: "No clinical testing was performed in association with this submission." Therefore, there is no information on the effect size of human reader improvement with or without AI assistance.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, a standalone performance assessment was done implicitly. The devices (InterView XP and InterView FUSION) are described as "Software as Medical Device (SaMD)" and their functionalities (image display, manipulation, enhancement, analysis, quantification) were validated through "Non-Clinical Testing" and comparison to a predicate device. This non-clinical testing focused on verifying that the software performed its intended functions according to its specifications and relevant standards, independently of a human user's diagnostic interpretation.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical software validation, the "ground truth" would be the software's own specifications, user needs, functional requirements, and component requirements, as traced and tested according to standards like IEC 62304. The testing aimed to verify that the software produced expected outputs and behaved as designed. Since no clinical testing was performed, there was no ground truth established based on expert consensus, pathology, or outcomes data related to diagnostic accuracy.

7. The sample size for the training set:

Not applicable / Not provided. The summary describes the device as post-processing and visualization software. It is not presented as an AI/ML device that requires a separate training set for algorithm development in the traditional sense. The software's functionalities are based on established image processing algorithms and principles rather than a learned model from a training data set specified in the submission.

8. How the ground truth for the training set was established:

Not applicable / Not provided. As mentioned above, a "training set" in the context of machine learning with a specific "ground truth" establishment method is not described in this 510(k) summary for these devices.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and 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.

March 29, 2023

Mediso Medical Imaging Systems, Ltd. % William McLain Sr. Consultant CRO Group, Inc. 342 E. Main Street, Suite 207 Leola, Pennsylvania 17540

Re: K221984

Trade/Device Name: InterView XP; InterView FUSION Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: February 24, 2023 Received: February 27, 2023

Dear William Mclain:

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

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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,

Dghx

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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221984

Device Name InterView XP

Indications for Use (Describe)

InterView XP is a Software as Medical Device (SaMD) aimed at reviewing medical images such as planar scans (Static, Whole Body, Dynamic, Multi-Gated) and tomographic scans (SPECT) acquired by gamma cameras. Review of other image modalities is also supported. Common Users for clinical purposes are trained medical professionals, including clinicians and technicians in hospitals or imaging centers. Software components provide functions for image display, manipulation, enhancements, analysis and quantification. This device is not indicated for mammography use or dental diagnostics. The software provides diagnostic information, however, diagnostic decision cannot be based solely on the software. InterView XP has no specific target population.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Indications for Use

510(k) Number (if known) K221984

Device Name InterView FUSION

Indications for Use (Describe)

InterView FUSION is a Software as Medical Device (SaMD) aimed at reviewing medical im- ages such as planar scans and tomographic scans from SPECT, PET, CT, and MRI modalities. Review of other image modalities is also supported. The common users for clinical purposes are trained medical professionals, including clinicians in hospitals or imaging centers. Software components provide functions for image display, manipulation, enhancements, analysis, and quantification. This device is not indicated for mammography use or dental diagnostics. The software provides diagnostic information - however, diagnostic decisions cannot be based solely on this software. InterView FUSION has no specific target population.

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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."

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510(k) Summary - InterView XP

Submission Owner and Correspondent

Submission Owner

Mediso Medical Imaging Systems, Ltd. Laborc utca 3. Budapest HUNGARY H-1037 Ph: +36-1-3993030 Email: info@mediso.hu

Submission Correspondent

CRO Group, Inc. 342 E. Main Street, Suite 207 Leola, PA 17540 Contact: William McLain Phone: 717-656-9656 E-Mail: bmclain@crogroup.com

Date Summary Prepared

February 23, 2023

Device Trade Name

InterView XP

Device Common Name

Medical Image Visualization And Post-processing Software As Medical Device (SaMD)

Device Classification Name

Medical Image Management and Processing System Classified as Class 2 at 21 CFR 892.2050, product code LLZ.

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Legally Marketed Device To Which The Device Is Substantially Equivalent

The InterView XP is substantially equivalent to the Xeleris V Processing and Review Systems cleared under K201103.

Description of the Device

General evaluation

General evaluation is a special procedure that has no predefined workflow steps. This procedure offers various tools that might be combined together to build a custom procedure. These tools are the same that are used in other procedures. Combined with user programming not only the workflow is customized but also the numerical results derived from processed data.

Indications for Use

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Comparison Table with Predicate Device

The following Table compares the technological characteristics between the proposed InterView XP and the predicate Xeleris V Processing and Review Systems cleared under K201103.

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Feature	Subject deviceInterView XP	Predicate deviceXeleris V Processing and Review Systems (K201103)	Comparison
Intended Use	InterView XP is an advanced medical imagevisualization and post-processing Software asMedical Device (SaMD) for clinical applications.InterView XP is specialized for Nuclear Medicineapplications focusing on planar, whole body andSPECT evaluations. InterView XP supportsSPECT reconstruction. The process ofquantitative evaluation is guided throughstandardized evaluation steps and supported byspecialized viewers and automated algorithms. Awide range of function-specialized tools enablemeasurement, manipulation, enhancement andanalysis of medical images. Data from Mediso orthird party manufacturer's devices may be passedto the application from the integrated database orother PACS systems. Data handling includesimages transfer, storage and printing capabilitiesof DICOM images. InterView XP is a stand-alonemedical software which can operate on dedicatedworkstations provided by the manufacturer.InterView XP is NOT intended to be used as areplacement for visual interpretation nor as adiagnostic tool without other clinical andlaboratory information. It is not intended to treatthe patient, to monitor vital signs or to give adirect diagnosis of disease.	Intended use & Indications for useThe system is intended for use by Nuclear Medicine(NM) or Radiology practitioners and referringphysicians. The intended use of the system is toprovide digital processing, review and reporting ofmedical images, including data display, qualitycontrol, image manipulation and quantificationanalysis, transfer, storage and printing capabilities.The system operates in a variety of configurations.The hardware components may include computerworkstations, Communications devices, videomonitors, data storage and hardcopy devices.Software components provide functions forperforming operations related to image display;manipulation, enhancements, analysis andquantification and can operate on dedicatedworkstations and client-server architectures.(....)*	Similarities:Each software is intended to beused for nuclear medicineapplications.Processing, review and reportingare the core functionalities.Both are Software as MedicalDevice (SaMD)Workstation or client-serverarchitecture is supported.Differences:N/AIntended use statement of InterView andXeleris software are substantiallyequivalent.
Feature	Subject deviceInterView XP	Predicate deviceXeleris V Processing and Review Systems(K201103)	Comparison
Indications for use	InterView XP is a Software as Medical Device(SaMD) aimed at reviewing medical images suchas planar scans (Static, Whole Body, Dynamic,Multi-Gated) and tomographic scans (SPECT,Gated SPECT) acquired by gamma cameras.Review of other image modalities is alsosupported. Common Users for clinical purposesare trained medical professionals, includingclinicians and technicians in hospitals or imagingcenters. Software components provide functionsfor image display, manipulation, enhancements,analysis and quantification. This device is notindicated for mammography use or dentaldiagnostics. The software provides diagnosticinformation; however, diagnostic decision cannotbe based solely on the software. InterView XPhas no specific target population.	The system is intended for use by Nuclear Medicine(NM) or Radiology practitioners and referringphysicians for display, processing, archiving, printing,reporting and networking of NMI data, includingplanar scans (Static, Whole Body, Dynamic, Multi-Gated) and tomographic scans (SPECT, GatedSPECT, dedicated PET or Camera-Based-PET)acquired by gamma cameras or PET scanners. Thesystem can run on dedicated workstation or in aserver-client configuration.The NM or PET data can be coupled with registeredand/or fused CT or MR scans, and with physiologicalsignals in order to depict, localize, and/or quantify thedistribution of radionuclide tracers and anatomicalstructures in scanned body tissue for clinicaldiagnostic purposes.	Similarities:- Intended users are the same.- Software core functionalities arethe same.- Both software process similarmodalities.- Both software support stand-alone and client-server architecture.Differences:- N/A- Indications for use statement of InterViewand Xeleris software are substantiallyequivalent.
Field of use	General nuclear medicine processing methods inthe field of Endocrinology, Cardiology,Osteology, Neurology, Nephrology, Hepatology,Gastroenterology, Pulmonology and other fieldsof nuclear medicine. SPECT reconstructionengine.	The system is intended for use by Nuclear Medicine(NM) or Radiology practitioners. Tools for generalnuclear medicine including but not limited toapplications for bone and cardiac, lung, renal,gallbladder, gastric brain, thyroid analysis. SPECTreconstruction methods included. Dosimetryapplications.	Similarities:- Nuclear medicine applications.Differences:- See detailed comparison below.- The field of use of InterView and Xelerissoftware is nuclear medicine. No impacton substantial equivalence.
Target population	No specifics target population.	Specifics target population is notdefined.Differences:- N/A	Similarities:- No specific target population.Differences:- N/A.- Neither InterView nor Xeleris has aspecifics target population. No impact onsubstantial equivalence.

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510(k) Summary - InterView X

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Feature	Subject deviceInterView XP	Predicate deviceXeleris V Processing and Review Systems(K201103)	Technical Characteristics	Comparison
Device design	Standalone Software with Graphical UserInterface (GUI) controlled by the peripherals ofthe workstation.InterView family are post-processing software,and they have no control over the imagegenerating devices.	Standalone Software with Graphical User Interface(GUI) controlled by the peripherals of the workstation.Xeleris is a post-processing software and has nocontrol over the image generating devices.		Similarities:Both softwares are GUI basedsoftware applications.Basic operational principles aresimilar.Neither software has impact onthe Image generating device.Differences:N/ADevice design of InterView and Xelerissoftware are substantially equivalent.
Host environment	Operates in a single user environment, on astand-alone workstation, or multi-userenvironment, on a server using Windows RemoteDesktop Protocol.Single user and client operation system areWindows 10, server operation system is WindowsServer 2019.	The system can run on dedicated workstation or in aserver-client configuration deployed on a virtualserver.Single user and client operation system are Windows10, server operation system is Windows Server 2016.		Similarities:Normal workstation and serverconfigurations.Each software is based onWindows Operating System.Differences:Different version of serveroperating system.Xeleris support virtualization.Different operating system version andvirtualization are not considered as asignificant technological difference. No

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Feature	Subject deviceInterView XP	Predicate deviceXeleris V Processing and Review Systems(K201103)	Clinical procedures -Cardiology	Comparison
SPECTreconstruction	Detect and correct motion; preview result;	Sinogram and linogram images for QC analysis;automatic gated and non-gated SPECT motioncorrection; tools for manual adjustment andcorrection		Similarities:Quality control beforereconstruction.Conventional reconstructionmethods.Reorientation methods.Differences:Iterative reconstructionalgorithm.
	Range; simultaneous reconstruction;reconstruction algorithms; iterative reconstruction;attenuation correction; material map for CT AC;manual registration; automatic registration;change AC; filters; reconstruction profiles;	Side-by-side reconstruction and auto reformat;filtered back projection; iterative reconstructionw/scatter correction and/or attenuation correction(where relevant data is provided); 3D Post-Filter;Chang Attenuation Correction; comprehensive reviewof all slice planes, 3-plane spot collection andtriangulation to show image interrelationships;		InterView and Xeleris has a differentimplementation of 3D iterative OSEMreconstruction that are based on themodelling of the same physical principles(attenuation, scatter correction); thereforeit can be considered as substantiallyequivalent.
	Manual reorientation; automatic reorientation;simultaneous reorientation; reoriented imageparameters	Supports reformat; oblique slices;		Similarities:Myocardial Perfusion SPECTanalysis.First-pass radionuclideangiography analysis.Equilibrium gated planarradionuclide ventriculographyanalysis.Differences:
	Myocardial Perfusion SPECT; MyocardialPerfusion Gated SPECT; Gated blood poolSPECT; Thallium-201 chloride or [99mTc]labelled SESTAMIBI or Tetrofosmin; visualassessment; perfusion, wall motion, andthickening on polar maps; circumferential profilecurves; global and regional ejection fraction; end-diastolic and end-systolic left ventricular volumesand stroke volume; launch third-party software;	Cardiac SPECT, gated SPECT, and PET dataincluding Sestamibi, Thallium, Tetrofosmin, DualIsotope, FOG, and Rubidium; review beating heartslices; Calculation of TID and lung heart ratio; PolarPlots and Reversibility Polar Plots; ejection fraction;masking; cardiac review screen; including 3D, PolarMaps, four sets, five slices review, ED/ES review,beating slices, EF, side-by-side perfusion and beatinggated review; Synchronized gated slice beating;Direct linkage with optional 3rd party packages		Gated blood pool SPECTanalysis.Minor differences in theprocessing methods.
	Gated blood pool SPECT; ventricle function onphase, motion and amplitude polar maps; phasehistogram and volume curve; global and regionalejection fraction	N/A (with third party cardiac SW)		InterView and Xeleris provide clinicalprocedures for cardiac analysis. Although
Feature	Subject deviceInterView XP	Predicate deviceXeleris V Processing and Review Systems(K201103)	Comparison
Clinicalprocedures -Endocrinology	First-pass radionuclide angiography; visualassessment; vena cava sup. transit time forquality control; cardiac output; Stroke volume;Mean Pulmonary Transit Time; PulmonaryCirculation Time; left to right shunt ratioEquilibrium gated planar radionuclideventriculography analysis; visual assessment;global ejection fraction; ejection and filling time;average heart cycle and heart rate, and thelower/upper limit of the R-R intervalThyroid [99mTc]-Pertechnetate uptake, weight,and geometry; Thyroid lodine uptake, weight andgeometry; visual assessment; normalized uptake;thyroid weight; estimation of activity to beadministered for the radioiodine therapyParathyroid dual label; [99mTc] MIBI, tetrofosmin,or thallium-chloride, the other with [123I] Nal or[99mTc] pertechnetate; visual assessment both thethyroid and abnormal parathyroid tissue;normalized difference imageThyroid I-123 clearance; [123I] sodium-iodide;visual assessment; clearance calculated from thetime activity curve	EF analysis with volume curve; left/right ventricleselection; auto/manual ROIs for systole and diastole;interactive beat selection; phase/Amplitude analysis;quality control review screen including transit times;pulmonary to system flow Used to determine theexistence and size of the inter-cardiac shuntsPeak Filling Rate protocol that includes the leftventricle (LV) emptying index and determines severaltiming, ejection fraction and rate parametersThyroid uptake index; 99mTc and I-131 static studies;statistics on the entire thyroid per thyroid lobe, or byregion (cold or hot spot)Parathyroid imaging analysis; dual isotope (99mTc &201TI); dual phase MIBIN/A	there might be some difference in theprocessing methods and the derivedparameters (e.g. intermediate results arealso displayed) cardiac processing of bothsoftware can be considered assubstantially equivalent.For gated blood pool SPECT analysis seereference device.Similarities:Thyroid uptake & geometryanalysis.Differences:Thyroid I-123 clearance.Thyroid I-123 clearance analysisprocedure is based on general principlesfor evaluating a series of static planarstudies, similar to dynamic planarprocessing. Activity changes over time ofregions are visualized and parameters ofthe time activity curves are calculated. Nospecific clinical parameters are derived.Although this procedure is not present inXeleris, this is not considered as asignificant difference between the twoproducts. No impact on substantialequivalence.

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Feature	Subject deviceInterView XP	Predicate deviceXeleris V Processing and Review Systems(K201103)	Comparison
Clinical procedures -Hepatology	Cholescintigraphy; [99mTc]-labeled IDAderivatives; visual assessment; time activitycurves; parameters derived from curves;gallbladder ejection fraction;	Gallbladder EF; ejection fraction; motion correction;	Similarities:Gallbladder analysis.Differences:- Liver first pass- Minor differences in theprocessing methods
	Static liver and spleen; [99mTc] sulfur colloid;visual assessment; descriptive statistics;	N/A	Static liver and spleen analysis procedureis based on general principles forevaluating a static planar study. Staticliver and spleen calculate a simple activityratio of the liver and spleen region.
	Liver first pass; [99mTc]-labeled IDA derivatives;visual assessment; hepatic perfusion index; timeactivity curves; parameters derived from curves	N/A	Liver first pass analysis procedure isbased on general principles for evaluatinga dynamic planar study. Activity changesover time of regions are visualized andparameters of the time activity curves arecalculated. No specific clinical parametersare derived.
			Although these procedures are notpresent in Xeleris, this is not consideredas a significant difference between thetwo products. No impact on substantialequivalence.

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Feature	Subject device	Predicate device(K201103)	Comparison
Clinicalprocedures -Nephrology	Dynamic Kidney; [Tc-99m] labeled DTPA, [Tc-99m] labeled MAG3, Tc-99m] labeled EC, [I-131]labeled OIH, [I-123] labeled OIH derivatives;visual assessment; time activity curves;parameters derived from curves; split renalfunction (integral, Patlak-Rutland method);transplanted kidney perfusion and function index;Hilson index; residual and normalized residualkidney activity (NORA); output efficiency; renalblood flow (RBF/CO); diuretic response;deconvolution and Patlak-Rutland plot analysis;urine flow rate; residual urine volume; gravity-assisted and post-void drainage parameters;parametric images: time of maximum, maximalcounts, mean transit timeStatic Kidney; [99mTc] labeled DMSA-derivatives;visual assessment; split renal function; uptake ofthe kidneys; different kidney depth estimationmethods	Xeleris V Processing and Review SystemsRenal analysis; renal perfusion; renal function;automatically identify kidney ROIs with manualadjustments; renogram for diuretic and captoprilacquisitions; DTPA, MAG3 and LASIX renography;DMSA Renal; pediatric kidney depth calculation;analysis methods include Gates GFR, QuantEM(Option); modified Gates, modified Schlegal; singlesample clearance include Dubovsky (for Ortho lodohippuran and 99mTc-MAG3) and Bubeck (99mTc-MAG3); perfusion methods include Hilson, Peter, andKirchner; relative uptake methods include Slope andIntegral methods; excretion index (20 min,30 min,residual); Manchester with Rutland slope for relativeuptake supportRenogram DMSA; relative and absolute function(%dose); three methods of entry of dose (camera,well counter, and dose calibrator); five methods ofkidney depth estimation (manual, Raynaud, Taylor,Tonnensen, and conjugate view)	Similarities:Dynamic kidney analysis.Static kidney analysis.Differences:Minor differences in theprocessing methods.InterView and Xeleris provide clinicalprocedures for kidney analysis. Althoughthere might be some difference in theprocessing methods and the derivedparameters (e.g. intermediate results arealso displayed) kidney processing of bothsoftware can be considered assubstantially equivalent.
Clinicalprocedures -Neurology	Brain fist-pass; [99mTc] HMPAO, [99mTc] RBC;visual assessment; mean transit time; perfusion;time activity curves; parameters derived fromcurves	N/A	Similarities:Brain perfusion analysis.DaTscan analysis.Differences:

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Subject deviceInterView XP	Predicate deviceXeleris V Processing and Review Systems(K201103)	Comparison
Brain perfusion; [99mTc] HMPAO; visualassessment; regional analysis	CBF Segmentation Protocol; Trans-axial slicesubdivided into equiangular sectors over 360degrees; Brain oblique reformatting; OM linedefinition with external marker; analysis of meancount, total count, maximum pixel value and standarddeviation; Early/Late and Right/Left Mean ratios -Quality control of reconstructed data; image slicecomparisons	Brain first-pass.Normal database of agematched reference values.Minor differences in theprocessing methods.
DaTscan; I-123 DaTscan; visual assessment;Statistics (mean counts, area...) of the striatalregions; count ratios	DaTQUANT optional application; visual evaluationand quantification of I-123-ioflupane images; elativecomparison of uptake ratios; pre-defined VOItemplate; database of age matched reference values	InterView and Xeleris provide clinicalprocedures for brain perfusion andDaTscan analysis. Although there mightbe some difference in the processingmethods and the derived parameters (e.g.intermediate results are also displayed)brain perfusion and DaTscan processingof both software can be considered assubstantially equivalent. Normal databaseof age matched reference values is notavailable in InterView but supported in thethird-party software that are optionallyprovided with InterView. This functionalityallows better interpretation of results butprocessing of DaTscan brain images ispossible even without a normal database.
		Brain first pass analysis procedure isbased on general principles for evaluatinga dynamic planar study. Activity changesover time of regions are visualized andparameters of the time activity curves arecalculated. No specific clinical parametersare derived. Although this procedure is notpresent in Xeleris, this is not consideredas a significant difference between thetwo products. No impact on substantialequivalence.

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Feature	Subject deviceInterView XP	Predicate deviceXeleris V Processing and Review Systems(K201103)	Comparison
Clinicalprocedures -Osteology	Whole body bone; visual assessment; basicstatistics;	Whole Body and Bone Spots Review; Review wholebody and spot images; dual zoom mode; predefinedautomatic layouts; regional masking; ROIcomparison-based analysis; statistic and countdisplay;	Similarities:• Whole body analysis.• 3-Phase Bone Scintigraphyanalysis.• Sacroiliac index analysis.Differences:• Minor differences in theprocessing methods.InterView and Xeleris provide clinicalprocedures for bone analysis. Althoughthere might be some difference in theprocessing methods and the derivedparameters (e.g. intermediate results arealso displayed) bone processing of bothsoftware can be considered assubstantially equivalent.
	3-Phase Bone Scintigraphy; [99mTc]-labelleddiphosphonates; visual assessment; uptake ratio Analysis of the perfusion and blood pool phases; ROIcomparison-based analysis; statistic and countdisplay;
	Sacroiliac Index; [99mTc]-labelleddiphosphonates; visual assessment; sacroiliacjoint-to-sacrum ratios; left-to-right (or right-to-left)sacroiliac count ratio	Sacroiliac ratio with manual or auto edge detection
Clinicalprocedures -Pulmonology	Lung Quantitative 6-Part; [99mTc] MAA, [99mTc]DTPA, Kr-81, Xe-133, Xe-127; visualassessment; basics statistics;	N/A	Similarities:• Lung ventilation and perfusionanalysis.Differences:• Lung shunt fraction.• Lung quantitative 6 part
	Combined Lung; Lung Quantitative 6-Part;[99mTc] MAA, [99mTc] DTPA, Kr-81, Xe-133, Xe-127; visual assessment;	Lung analysis; analysis of lung ventilation andperfusion; ventilation index and quantitative perfusionanalysis including ratio; templates for lung segmentsvisualization;	Lung shunt fraction and lung quantitative6-Part analysis procedure is based ongeneral principles for evaluating a static
		N/A

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Feature	Subject deviceInterView XP	Predicate deviceXeleris V Processing and Review Systems(K201103)	Comparison
	Lung shunt fraction; [99mTc] MAA; visualassessment; lung shunt index;		planar study. Lung shunt fractioncalculates a simple activity ratio of thelung and liver region (total lung counts) /(total lung counts + total liver counts).Lung quantitative 6-Part simple calculatesactivities in 6 regions of the lung.Although these procedures are notpresent in Xeleris, this is not consideredas a significant difference between thetwo products. No impact on substantialequivalence.

ndication for use of the dedicated applications of GE Xeleris system is not included in the comparison, only the general part

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Non-Clinical Testing

Nonclinical testing consisted of a software validation that traced and tested all identified inputs and requirements. This testing consisted of the establishment of User Needs, Functional System Requirement, and Component Requirement Specifications. Test cases were executed to verify that these requirements were fulfilled. Clinical effectiveness was assessed through the completion of Functional Design Validations and Usability Validations. Acceptance criteria were fulfilled. Testing was based on:

. IEC 62304:2006 + A1/2015, Medical device software. Software life-cycle processes
IEC 62366-1:2015, Medical devices. Part 1: Application of usability engineering to . medical devices
ISO 12052:2017, Health informatics. Digital imaging and communication in medicine ● (DICOM) including workflow and data management
NEMA PS3, DICOM PS 3.x standard-series ●
General Principles of Software Validation; Final Guidance for Industry and FDA Staff, . Issued January 11, 2002

Clinical Testing

No clinical testing was performed in association with this submission.

Conclusions

In conclusion, the results of the comparison of design, materials, intended use and technological characteristics and the performance test demonstrate that the InterView XP is substantially equivalent to the predicate device.

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510(k) Summary - InterView FUSION

Submission Owner and Correspondent

Submission Owner

Mediso Medical Imaging Systems, Ltd. Laborc utca 3. Budapest HUNGARY H-1037 Ph: +36-1-3993030 Email: info@mediso.hu

Submission Correspondent

CRO Group, Inc. 342 E. Main Street, Suite 207 Leola, PA 17540 Contact: William McLain Phone: 717-656-9656 E-Mail: bmclain@crogroup.com

Date Summary Prepared

February 23, 2023

Device Trade Name

InterView FUSION

Device Common Name

Medical Image Visualization And Post-processing Software As Medical Device (SaMD)

Device Classification Name

Medical Image Management and Processing System Classified as Class 2 at 21 CFR 892.2050. product code LLZ.

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Legally Marketed Device To Which The Device Is Substantially Equivalent

The InterView FUSION is substantially equivalent to the Xeleris V Processing and Review Systems cleared under K201103.

Description of the Device

Multi-modal registration and fusion of SPECT, PET, CT and MRI studies is a core functionality of InterView FUSION. Evaluation can be performed with the help of several specialized viewers and automated algorithms. Statistical measurements by ROIs, VOIs are present just as well as SUV representation for PET and even SPECT images. A wide range of function-specialized tools provide a well-detailed, fast and easy evaluation of medical images combining with advanced visualizations and interactions with flexible workspaces. Special segmentation methods provide quick and easy extraction of organs/regions from images. Basic arithmetic operations as well as spatial and frequency domain filters are also available.

Indications for Use

InterView FUSION is a Software as Medical Device (SaMD) aimed at reviewing medical images such as planar scans and tomographic scans from SPECT, PET, CT, and MRI modalities. Review of other image modalities is also supported. The common users for clinical purposes are trained medical professionals, including clinicians and technicians in hospitals or imaging centers. Software components provide functions for image display, manipulation, enhancements, analysis, and quan- tification. This device is not indicated for mammography use or dental diagnostics. The software provides diagnostic information - however, diagnostic decisions cannot be based solely on this software. InterView FUSION has no specific target population.

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Technological Characteristics

The following Table compares the technological characteristics between the proposed InterView FUSION and the predicate Xeleris V Processing and Review Systems cleared under K201103.

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Feature	Subject deviceInterView FUSION	Predicate deviceXeleris V Processing and Review Systems (K201103)	Comparison
Intended Use	InterView FUSION is an advanced multi-modalitymedical image visualization and post-processingSoftware as Medical Device (SaMD) for clinicalapplications. Multi-modal registration and fusion offunctional - SPECT, PET - and anatomical - CT,MRI - studies are a core functionality. Quantitativeevaluation can be performed with the help ofseveral specialized viewers, flexible workspacesand automated algorithms. A wide range offunction-specialized tools enable measurement,manipulation, enhancement and analysis of theimages. Data from Mediso or third-partymanufacturer's devices may be passed to theapplication from the integrated database or otherPACS systems. InterView FUSION is a stand-alonemedical software. InterView FUSION is NOTintended to be used as a replacement for visualinterpretation nor as a diagnostic tool without otherclinical and laboratory information. It is not intendedto treat the patient, to monitor vital signs or to give adirect diagnosis of disease.	The system is intended for use by NuclearMedicine (NM) or Radiology practitionersand referring physicians. The intended useof the system is to provide digital processing,review and reporting of medical images,including data display, quality control, imagemanipulation and quantification analysis,transfer, storage and printing capabilities.The system operates in a variety ofconfigurations. The hardware componentsmay include computer workstations,Communications devices, video monitors,data storage and hardcopy devices.Software components provide functions forperforming operations related to imagedisplay; manipulation, enhancements,analysis and quantification and can operateon dedicated workstations and client-serverarchitectures.(....)*	Similarities:Each software is intended to be used fornuclear medicine applications.Processing, review and reporting are thecore functionalities.Both are Software as Medical Device(SaMD)Workstation or client-server architectureis supported.Differences:N/AIntended use statement of InterView and Xelerissoftware are substantially equivalent.
Indications foruse	InterView FUSION is a Software as Medical Device(SaMD) aimed at reviewing medical images such asplanar scans and tomographic scans from SPECT,PET, CT and MRI modalities. Review of other imagemodalities is also supported. Common Users forclinical purposes are trained medical professionals,including clinicians and technicians in hospitals orimaging centers. Software components providefunctions for image display, manipulation,	The system is intended for use by NuclearMedicine (NM) or Radiology practitionersand referring physicians for display,processing, archiving, printing, reporting andnetworking of NMI data, including planarscans (Static, Whole Body, Dynamic,Multi-Gated) and tomographic scans(SPECT, Gated SPECT, dedicated PET orCamera-Based-PET) acquired by gamma	Similarities:Intended users are the same.Software core functionalities are thesame.Both software process similarmodalities.Both software support stand-alone andclient-server architecture.

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Feature	Subject deviceInterView FUSION	Predicate deviceXeleris V Processing and ReviewSystems (K201103)	Comparison
	enhancements, analysis and quantification. Thisdevice is not indicated for mammography use ordental diagnostics. The software providesdiagnostic information, however diagnostic decisioncannot be based solely on the software. InterViewFUSION has no specific target population.	cameras or PET scanners. The system canrun on dedicated workstation or in aserver-client configuration.The NM or PET data can be coupled withregistered and/or fused CT or MR scans,and with physiological signals in order todepict, localize, and/or quantify thedistribution of radionuclide tracers andanatomical structures in scanned body tissuefor clinical diagnostic purposes.	Differences:N/AIndications for use statement of InterView andXeleris software are substantially equivalent.
ClinicalproceduresLesion detectionmethod	Lesion detection method; detection range; maskregions; global threshold method; local thresholdmethod; lymph node package method	Q. Volumetrix Al; quantitative SPECT/PETresults are further enhanced with advancedsegmentation tools providing 2D and 3Dorgan and lesion characterization.	Similarities:Lesion detection.Differences:Minor differences in the processingmethods.InterView and Xeleris provide a clinical procedurefor lesion detection. Lesion detection is anadvanced segmentation method that facilitatesthe segmentation of lesions (regions with higheractivity on NM images). Different manual andautomatic methods might be applied to find theproper lesion contour. Although there aredifferences in the applied techniques it shall beconsidered as substantially equivalent.
ClinicalproceduresFollow-upmethod	Follow-up method; quality control; register images;compare images; copy baseline findings; propagatefindings; overview findings; display results; managefollow-up finding	Q. Volumetrix Al; quantitative patientfollow-up; two instances of the sameapplication with two different studies of thesame patient	Similarities:Follow-up analysis.Differences:Minor differences in the workflowInterView and Xeleris provide a clinical procedurefor follow-up analysis that is comparing a patientearlier studied with the current ones. The essence

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Feature	Subject device	Predicate device	Comparison
	InterView FUSION	Xeleris V Processing and ReviewSystems (K201103)	of the procedure is to provide a simple workflowthat facilitates processing. Although there aredifferences in the workflow, it shall be consideredas substantially equivalent.

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Non-Clinical Testing

IEC 62304:2006 + A1/2015, Medical device software. Software life-cycle processes ●
IEC 62366-1:2015, Medical devices. Part 1: Application of usability engineering to ● medical devices
ISO 12052:2017, Health informatics. Digital imaging and communication in medicine . (DICOM) including workflow and data management
NEMA PS3, DICOM PS 3.x standard-series
General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Issued January 11, 2002

Clinical Testing

No clinical testing was performed in association with this submission.

Conclusions

In conclusion, the results of the comparison of design, materials, intended use and technological characteristics and the performance test demonstrate that the InterView FUSION is substantially equivalent to the predicate device.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).