Who is the manufacturer of InterView XP; InterView FUSION?

Mediso Medical Imaging Systems, Lttd. filed the 510(k) submission for InterView XP; InterView FUSION (K221984).

What is the FDA product code for InterView XP; InterView FUSION?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for InterView XP; InterView FUSION?

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

Who can help prepare an FDA 510(k) submission like InterView XP; InterView FUSION?

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.

InterView XP; InterView FUSION

Q: What are the predicate devices for InterView XP; InterView FUSION?

Xeleris V Processing and Review Systems (K201103).

K221984 · Mediso Medical Imaging Systems, Lttd. · LLZ · Mar 29, 2023 · Radiology

Device Facts

Record ID	K221984
Device Name	InterView XP; InterView FUSION
Applicant	Mediso Medical Imaging Systems, Lttd.
Product Code	LLZ · Radiology
Decision Date	Mar 29, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

InterView XP is an advanced medical image visualization and post-processing Software as Medical Device (SaMD) for clinical applications. InterView XP is specialized for Nuclear Medicine applications focusing on planar, whole body and SPECT evaluations. InterView XP supports SPECT reconstruction. The process of quantitative evaluation is guided through standardized evaluation steps and supported by specialized viewers and automated algorithms. A wide range of function-specialized tools enable measurement, manipulation, enhancement and analysis of medical images. Data from Mediso or third party manufacturer's devices may be passed to the application from the integrated database or other PACS systems. Data handling includes images transfer, storage and printing capabilities of DICOM images. InterView XP is a stand-alone medical software which can operate on dedicated workstations provided by the manufacturer. InterView XP is NOT intended to be used as a replacement for visual interpretation nor as a diagnostic tool without other clinical and laboratory information. It is not intended to treat the patient, to monitor vital signs or to give a direct diagnosis of disease.

Device Story

InterView XP is a standalone DICOM-compatible SaMD for nuclear medicine image visualization and post-processing. It processes planar and tomographic (SPECT) scans acquired by gamma cameras. The software provides tools for image display, manipulation, enhancement, analysis, and quantification. It operates on Windows-based workstations. Clinicians and technicians use the software to review images and perform quantitative evaluations guided by standardized steps and automated algorithms. The device provides diagnostic information to support clinical decision-making but is not a replacement for visual interpretation or a standalone diagnostic tool. It does not control image-generating hardware. Benefits include standardized analysis workflows and flexible tools for measuring and manipulating nuclear medicine data.

Clinical Evidence

No clinical testing was performed. Evidence consists of bench-only software validation, including functional design validation and usability validation, confirming that all user needs and system requirements were met.

Technological Characteristics

Standalone software operating on Windows 10/Server 2019. DICOM 3.0 compatible. Implements 3D iterative OSEM reconstruction, filtering, and registration algorithms. Complies with IEC 62304 (software lifecycle), IEC 62366-1 (usability), and ISO 12052/NEMA PS3 (DICOM).

Indications for Use

Indicated for reviewing medical images including planar scans (Static, Whole Body, Dynamic, Multi-Gated) and tomographic scans (SPECT, Gated SPECT) acquired by gamma cameras. Intended for use by trained medical professionals (clinicians, technicians) in hospitals or imaging centers. No specific target population. Not indicated for mammography or dental diagnostics.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

Xeleris V Processing and Review Systems (K201103)

Related Devices

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K160426 — syngo.via MI Workflows · Siemens Medical Solutions USA, Inc. · Mar 4, 2016
K160334 — Advanced Medical Imaging Software Suite (KSWVWR) · Keosys Sas · Jun 21, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ### 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) ### 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}------------------------------------------------ ### 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.* 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." {4}------------------------------------------------ # 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. {5}------------------------------------------------ # 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 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. ### 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 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. {6}------------------------------------------------ ## 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. {7}------------------------------------------------ | Feature | Subject device InterView XP | Predicate device Xeleris V Processing and Review Systems (K201103) | Comparison | |---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | InterView XP is an advanced medical image visualization and post-processing Software as Medical Device (SaMD) for clinical applications. InterView XP is specialized for Nuclear Medicine applications focusing on planar, whole body and SPECT evaluations. InterView XP supports SPECT reconstruction. The process of quantitative evaluation is guided through standardized evaluation steps and supported by specialized viewers and automated algorithms. A wide range of function-specialized tools enable measurement, manipulation, enhancement and analysis of medical images. Data from Mediso or third party manufacturer's devices may be passed to the application from the integrated database or other PACS systems. Data handling includes images transfer, storage and printing capabilities of DICOM images. InterView XP is a stand-alone medical software which can operate on dedicated workstations provided by the manufacturer. InterView XP is NOT intended to be used as a replacement for visual interpretation nor as a diagnostic tool without other clinical and laboratory information. It is not intended to treat the patient, to monitor vital signs or to give a direct diagnosis of disease. | Intended use & Indications for use The system is intended for use by Nuclear Medicine (NM) or Radiology practitioners and referring physicians. The intended use of the system is to provide digital processing, review and reporting of medical images, including data display, quality control, image manipulation and quantification analysis, transfer, storage and printing capabilities. The system operates in a variety of configurations. The hardware components may include computer workstations, Communications devices, video monitors, data storage and hardcopy devices. Software components provide functions for performing operations related to image display; manipulation, enhancements, analysis and quantification and can operate on dedicated workstations and client-server architectures. (....)* | Similarities: Each software is intended to be used for nuclear medicine applications. Processing, review and reporting are the core functionalities. Both are Software as Medical Device (SaMD) Workstation or client-server architecture is supported. Differences: N/A Intended use statement of InterView and Xeleris software are substantially equivalent. | | Feature | Subject device InterView XP | Predicate device Xeleris V Processing and Review Systems (K201103) | Comparison | | Indications for use | 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. | The system is intended for use by Nuclear Medicine (NM) or Radiology practitioners and referring physicians for display, processing, archiving, printing, reporting and networking of NMI data, including planar scans (Static, Whole Body, Dynamic, Multi- Gated) and tomographic scans (SPECT, Gated SPECT, dedicated PET or Camera-Based-PET) acquired by gamma cameras or PET scanners. The system can run on dedicated workstation or in a server-client configuration. The NM or PET data can be coupled with registered and/or fused CT or MR scans, and with physiological signals in order to depict, localize, and/or quantify the distribution of radionuclide tracers and anatomical structures in scanned body tissue for clinical diagnostic purposes. | Similarities: - Intended users are the same. - Software core functionalities are the same. - Both software process similar modalities. - Both software support stand-alone and client-server architecture. Differences: - N/A - Indications for use statement of InterView and Xeleris software are substantially equivalent. | | Field of use | General nuclear medicine processing methods in the field of Endocrinology, Cardiology, Osteology, Neurology, Nephrology, Hepatology, Gastroenterology, Pulmonology and other fields of nuclear medicine. SPECT reconstruction engine. | The system is intended for use by Nuclear Medicine (NM) or Radiology practitioners. Tools for general nuclear medicine including but not limited to applications for bone and cardiac, lung, renal, gallbladder, gastric brain, thyroid analysis. SPECT reconstruction methods included. Dosimetry applications. | Similarities: - Nuclear medicine applications. Differences: - See detailed comparison below. - The field of use of InterView and Xeleris software is nuclear medicine. No impact on substantial equivalence. | | Target population | No specifics target population. | Specifics target population is not defined. Differences: - N/A | Similarities: - No specific target population. Differences: - N/A. - Neither InterView nor Xeleris has a specifics target population. No impact on substantial equivalence. | {8}------------------------------------------------ # 510(k) Summary - InterView X {9}------------------------------------------------ | XP | |----------------------| | iew 11 | | inter' | | I | | ry a imm Su | | 0(k) | | | | 510 | | Feature | Subject device InterView XP | Predicate device Xeleris V Processing and Review Systems (K201103) | Technical Characteristics | Comparison | |------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device design | Standalone Software with Graphical User Interface (GUI) controlled by the peripherals of the workstation. InterView family are post-processing software, and they have no control over the image generating devices. | Standalone Software with Graphical User Interface (GUI) controlled by the peripherals of the workstation. Xeleris is a post-processing software and has no control over the image generating devices. | | Similarities: Both softwares are GUI based software applications. Basic operational principles are similar. Neither software has impact on the Image generating device. Differences: N/A Device design of InterView and Xeleris software are substantially equivalent. | | Host environment | Operates in a single user environment, on a stand-alone workstation, or multi-user environment, on a server using Windows Remote Desktop Protocol. Single user and client operation system are Windows 10, server operation system is Windows Server 2019. | The system can run on dedicated workstation or in a server-client configuration deployed on a virtual server. Single user and client operation system are Windows 10, server operation system is Windows Server 2016. | | Similarities: Normal workstation and server configurations. Each software is based on Windows Operating System. Differences: Different version of server operating system. Xeleris support virtualization. Different operating system version and virtualization are not considered as a significant technological difference. No | {10}------------------------------------------------ | XP | |-------------------| | ew 19 | | ntei | | I A | | S a mm C | | SI C 0(k) | | 51 | {11}------------------------------------------------ | XP | |----------------------| | iew 11 | | inter' | | I | | ry a imm Su | | 0(k) | | | | 510 | | Feature | Subject device InterView XP | Predicate device Xeleris V Processing and Review Systems (K201103) | Clinical procedures - Cardiology | Comparison | |-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | SPECT reconstruction | Detect and correct motion; preview result; | Sinogram and linogram images for QC analysis; automatic gated and non-gated SPECT motion correction; tools for manual adjustment and correction | | Similarities: Quality control before reconstruction. Conventional reconstruction methods. Reorientation methods. Differences: Iterative reconstruction algorithm. | | | 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 reconstruction w/scatter correction and/or attenuation correction (where relevant data is provided); 3D Post-Filter; Chang Attenuation Correction; comprehensive review of all slice planes, 3-plane spot collection and triangulation to show image interrelationships; | | InterView and Xeleris has a different implementation of 3D iterative OSEM reconstruction that are based on the modelling of the same physical principles (attenuation, scatter correction); therefore it can be considered as substantially equivalent. | | | Manual reorientation; automatic reorientation; simultaneous reorientation; reoriented image parameters | Supports reformat; oblique slices; | | Similarities: Myocardial Perfusion SPECT analysis. First-pass radionuclide angiography analysis. Equilibrium gated planar radionuclide ventriculography analysis. Differences: | | | Myocardial Perfusion SPECT; Myocardial Perfusion Gated SPECT; Gated blood pool SPECT; Thallium-201 chloride or [99mTc] labelled SESTAMIBI or Tetrofosmin; visual assessment; perfusion, wall motion, and thickening on polar maps; circumferential profile curves; global and regional ejection fraction; end- diastolic and end-systolic left ventricular volumes and stroke volume; launch third-party software; | Cardiac SPECT, gated SPECT, and PET data including Sestamibi, Thallium, Tetrofosmin, Dual Isotope, FOG, and Rubidium; review beating heart slices; Calculation of TID and lung heart ratio; Polar Plots and Reversibility Polar Plots; ejection fraction; masking; cardiac review screen; including 3D, Polar Maps, four sets, five slices review, ED/ES review, beating slices, EF, side-by-side perfusion and beating gated review; Synchronized gated slice beating; Direct linkage with optional 3rd party packages | | Gated blood pool SPECT analysis. Minor differences in the processing methods. | | | Gated blood pool SPECT; ventricle function on phase, motion and amplitude polar maps; phase histogram and volume curve; global and regional ejection fraction | N/A (with third party cardiac SW) | | InterView and Xeleris provide clinical procedures for cardiac analysis. Although | | Feature | Subject device InterView XP | Predicate device Xeleris V Processing and Review Systems (K201103) | Comparison | | | Clinical procedures - Endocrinology | First-pass radionuclide angiography; visual assessment; vena cava sup. transit time for quality control; cardiac output; Stroke volume; Mean Pulmonary Transit Time; Pulmonary Circulation Time; left to right shunt ratio Equilibrium gated planar radionuclide ventriculography analysis; visual assessment; global ejection fraction; ejection and filling time; average heart cycle and heart rate, and the lower/upper limit of the R-R interval Thyroid [99mTc]-Pertechnetate uptake, weight, and geometry; Thyroid lodine uptake, weight and geometry; visual assessment; normalized uptake; thyroid weight; estimation of activity to be administered for the radioiodine therapy Parathyroid dual label; [99mTc] MIBI, tetrofosmin, or thallium-chloride, the other with [123I] Nal or [99mTc] pertechnetate; visual assessment both the thyroid and abnormal parathyroid tissue; normalized difference image Thyroid I-123 clearance; [123I] sodium-iodide; visual assessment; clearance calculated from the time activity curve | EF analysis with volume curve; left/right ventricle selection; 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 the existence and size of the inter-cardiac shunts Peak Filling Rate protocol that includes the left ventricle (LV) emptying index and determines several timing, ejection fraction and rate parameters Thyroid uptake index; 99mTc and I-131 static studies; statistics on the entire thyroid per thyroid lobe, or by region (cold or hot spot) Parathyroid imaging analysis; dual isotope (99mTc & 201TI); dual phase MIBI N/A | there might be some difference in the processing methods and the derived parameters (e.g. intermediate results are also displayed) cardiac processing of both software can be considered as substantially equivalent. For gated blood pool SPECT analysis see reference device. Similarities: Thyroid uptake & geometry analysis. Differences: Thyroid I-123 clearance. Thyroid I-123 clearance analysis procedure is based on general principles for evaluating a series of static planar studies, similar to dynamic planar processing. Activity changes over time of regions are visualized and parameters of the time activity curves are calculated. No specific clinical parameters are derived. Although this procedure is not present in Xeleris, this is not considered as a significant difference between the two products. No impact on substantial equivalence. | | {12}------------------------------------------------ {13}------------------------------------------------ {14}------------------------------------------------ | Feature | Subject device InterView XP | Predicate device Xeleris V Processing and Review Systems (K201103) | Comparison | |-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Clinical procedures - Hepatology | Cholescintigraphy; [99mTc]-labeled IDA derivatives; visual assessment; time activity curves; parameters derived from curves; gallbladder ejection fraction; | Gallbladder EF; ejection fraction; motion correction; | Similarities: Gallbladder analysis. Differences: - Liver first pass - Minor differences in the processing methods | | | Static liver and spleen; [99mTc] sulfur colloid; visual assessment; descriptive statistics; | N/A | Static liver and spleen analysis procedure is based on general principles for evaluating a static planar study. Static liver and spleen calculate a simple activity ratio of the liver and spleen region. | | | Liver first pass; [99mTc]-labeled IDA derivatives; visual assessment; hepatic perfusion index; time activity curves; parameters derived from curves | N/A | Liver first pass analysis procedure is based on general principles for evaluating a dynamic planar study. Activity changes over time of regions are visualized and parameters of the time activity curves are calculated. No specific clinical parameters are derived. | | | | | Although these procedures are not present in Xeleris, this is not considered as a significant difference between the two products. No impact on substantial equivalence. | {15}------------------------------------------------ | Feature | Subject device | Predicate device (K201103) | Comparison | |----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Clinical procedures - 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 renal function (integral, Patlak-Rutland method); transplanted kidney perfusion and function index; Hilson index; residual and normalized residual kidney activity (NORA); output efficiency; renal blood 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, maximal counts, mean transit time Static Kidney; [99mTc] labeled DMSA-derivatives; visual assessment; split renal function; uptake of the kidneys; different kidney depth estimation methods | Xeleris V Processing and Review Systems Renal analysis; renal perfusion; renal function; automatically identify kidney ROIs with manual adjustments; renogram for diuretic and captopril acquisitions; DTPA, MAG3 and LASIX renography; DMSA Renal; pediatric kidney depth calculation; analysis methods include Gates GFR, QuantEM (Option); modified Gates, modified Schlegal; single sample clearance include Dubovsky (for Ortho lodo hippuran and 99mTc-MAG3) and Bubeck (99mTc- MAG3); perfusion methods include Hilson, Peter, and Kirchner; relative uptake methods include Slope and Integral methods; excretion index (20 min,30 min, residual); Manchester with Rutland slope for relative uptake support Renogram DMSA; relative and absolute function (%dose); three methods of entry of dose (camera, well counter, and dose calibrator); five methods of kidney depth estimation (manual, Raynaud, Taylor, Tonnensen, and conjugate view) | Similarities: Dynamic kidney analysis. Static kidney analysis. Differences: Minor differences in the processing methods. InterView and Xeleris provide clinical procedures for kidney analysis. Although there might be some difference in the processing methods and the derived parameters (e.g. intermediate results are also displayed) kidney processing of both software can be considered as substantially equivalent. | | Clinical procedures - Neurology | Brain fist-pass; [99mTc] HMPAO, [99mTc] RBC; visual assessment; mean transit time; perfusion; time activity curves; parameters derived from curves | N/A | Similarities: Brain perfusion analysis. DaTscan analysis. Differences: | {16}------------------------------------------------ | Feature | Subject device InterView XP | Predicate device Xeleris V Processing and Review Systems (K201103) | Comparison | |---------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Brain perfusion; [99mTc] HMPAO; visual assessment; regional analysis | CBF Segmentation Protocol; Trans-axial slice subdivided into equiangular sectors over 360 degrees; Brain oblique reformatting; OM line definition with external marker; analysis of mean count, total count, maximum pixel value and standard deviation; Early/Late and Right/Left Mean ratios - Quality control of reconstructed data; image slice comparisons | Brain first-pass. Normal database of age matched reference values. Minor differences in the processing methods. | | | DaTscan; I-123 DaTscan; visual assessment; Statistics (mean counts, area...) of the striatal regions; count ratios | DaTQUANT optional application; visual evaluation and quantification of I-123-ioflupane images; elative comparison of uptake ratios; pre-defined VOI template; database of age matched reference values | InterView and Xeleris provide clinical procedures for brain perfusion and DaTscan analysis. Although there might be some difference in the processing methods and the derived parameters (e.g. intermediate results are also displayed) brain perfusion and DaTscan processing of both software can be considered as substantially equivalent. Normal database of age matched reference v…