(62 days)
No
The summary describes standard image processing, quantification, and visualization tools common in nuclear medicine workstations. There is no mention of AI, ML, or related terms, nor any description of training or testing data sets indicative of an AI/ML model.
No
The device is described as a workstation for processing, analyzing, and displaying medical imaging data for diagnostic purposes, not for providing therapy or treatment.
Yes
The device is described as assisting "the physician in diagnosis and/or treatment planning" and for "clinical diagnostic purposes," explicitly stating its role in diagnosis.
No
The device is described as a "Processing and Reviewing Workstation" which can be a "separate standalone post processing workstation" or "part of the FDA cleared D-SPECT® Cardiac Scanner System". While it is based on a Windows operating system and includes software options, the description implies it is a physical workstation (hardware) running the software, not just the software itself. It processes data from imaging hardware (gamma cameras, CT, MR).
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples (like blood, urine, tissue) outside the body. The D-SPECT® Processing and Reviewing Workstation processes and analyzes imaging data acquired from a patient's body using a gamma camera and other imaging modalities.
- The intended use and device description clearly focus on processing, analyzing, and displaying medical images. The data comes from the patient's body, not from a biological sample taken from the patient.
Therefore, the D-SPECT® Processing and Reviewing Workstation falls under the category of medical imaging software or a medical image processing workstation, not an IVD.
N/A
Intended Use / Indications for Use
The D-SPECT® Processing and Reviewing Workstation is intended for Processing, Reporting, Archiving, Display, Communication and Analysis of emission computerized tomography data using tools for imaging and automated review and quantification of Cardiac SPECT data.
The D-SPECT® Processing and Reviewing Workstation is intended to work with Spectrum Dynamics' D-SPECT® Cardiac Scanner System or as a separate standalone post processing workstation.
The system is intended for use by the Nuclear Medicine (NM), Radiology or Electro Physiology practitioners and referring physicians for display, processing, archiving, printing, reporting and networking of NMI data, including planar scans (Static, Dynamic, Multi-Gated) and tomographic three-dimensional scans (SPECT, Gated SPECT) acquired by gamma cameras. The system can run on a dedicated workstation or as part of Spectrum Dynamics' D-SPECT® Cardiac Scanner System. The NM data can be coupled with registered and/or fused X-Ray 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. "SUMO" optional application enables visual evaluation and assessment of the sympathetic innervation system of the heart by quantification of uptake ratios between regions of interest, identifying discreet uptake areas of mIBG I-123 (AdreView tm Iobenguane I-123 Injection) or similar agents within the heart.
Product codes
KPS, LLZ
Device Description
D-SPECT® Processing and Reviewing Workstation is intended for acceptance, transfer, display, storage, and processing of images for detection of radioisotope tracer uptakes in the patient's body. The device using various processing modes supported by the various clinical applications and various features designed to enhance image quality. The emission computerized tomography data can be coupled with registered and/or fused CT/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. Visualization tools include segmentation, color coding, and polar maps. Analysis tools include Quantitative Perfusion SPECT (QPS), Quantitative Gated SPECT (QGS) and Quantitative Blood Pool Gated SPECT (QBS) measurements, Multi Gated Acquisition (MUGA) and Heart-to-Mediastinum activity ratio (H/M). It also includes reporting tools for formatting findings and user selected areas of interest. It is capable of processing and displaying the acquired information in traditional formats, as well as in three-dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs.
D-SPECT® Processing and Reviewing Workstation is based on Windows operating system. Due to special customer requirements and the clinical focus the D-SPECT® Processing and Reviewing Workstation can be configured in the same way as the predicate device with different combinations of Windows OS based software options and clinical applications which are intended to assist the physician in diagnosis and/or treatment planning. This includes commercially available post-processing software packages.
D-SPECT® Processing and Reviewing Workstation is a processing workstation primarily intended for, but not limited to cardiac applications. The workstation can be a part of the FDA cleared D-SPECT® Cardiac Scanner System (K110507) or integrated to a separate standalone post processing station. "SUMO" optional application enables visual evaluation and assessment of the sympathetic innervation system of the heart by quantification of uptake ratios between regions of interest, identifying discreet uptake areas within the heart of mIBG I-123 (AdreView™ Iobenguane I-123 Injection) or similar agents.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
emission computerized tomography, planar scans (Static, Dynamic, Multi-Gated), tomographic three-dimensional scans (SPECT, Gated SPECT), X-Ray CT, MR scans
Anatomical Site
Cardiac, heart, scanned body tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Nuclear Medicine (NM), Radiology or Electro Physiology practitioners and referring physicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing demonstrated that the D-SPECT® Processing and Reviewing Workstation is as safe and effective as the cleared predicate devices.
The performance tests were done in addition to the successful completion of verification and validation testing as required by Spectrum Dynamics Medical quality system (per 21CFR 820 Quality System Regulation and ISO 13485 standard). Engineering testing and standards compliance testing were successfully conducted and did not raise any new safety questions or identify any new risks.
To demonstrate and validate the safety, effectiveness and clinical use of the modified D-SPECT® Processing and Reviewing Workstation using SUMO application, Spectrum Dynamics performed a number of validation and verification tests including overall performance study using a simulated phantom and a dataset of subjects in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff, Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data -Premarket Notification [510(k)] Submissions.
The performance tests indicate that the D-SPECT® Processing and Reviewing Workstation meets the specification requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 21, 2016
Spectrum Dynamics, Medical Ltd. % Mr. Yoram Levy OA/RA Consultant Qsite 31 Haavoda Street Binyamina, 30500 ISRAEL
Re: K160120
Trade/Device Name: D-SPECT® Processing and Reviewing Workstation Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: II Product Code: KPS, LLZ Dated: January 13, 2016 Received: January 19, 2016
Dear Mr. Levy:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D. O'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160120
Device Name
The D-SPECT® Processing and Reviewing Workstation
Indications for Use (Describe)
The D-SPECT® Processing and Reviewing Workstation is intended for Processing, Reporting, Archiving, Display, Communication and Analysis of emission computerized tomography data using tools for imaging and automated review and quantification of Cardiac SPECT data.
The D-SPECT® Processing and Reviewing Workstation is intended to work with Spectrum Dynamics' D-SPECT® Cardiac Scanner System or as a separate standalone post processing workstation.
The system is intended for use by the Nuclear Medicine (NM), Radiology or Electro Physiology practitioners and referring physicians for display, processing, archiving, printing, reporting and networking of NMI data, including planar scans (Static, Dynamic, Multi-Gated) and tomographic three-dimensional scans (SPECT, Gated SPECT) acquired by gamma cameras. The system can run on a dedicated workstation or as part of Spectrum Dynamics' D-SPECT® Cardiac Scanner System. The NM data can be coupled with registered and/or fused X-Ray 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. "SUMO" optional application enables visual evaluation and assessment of the sympathetic innervation system of the heart by quantification of uptake ratios between regions of interest, identifying discreet uptake areas of mIBG I-123 (AdreView tm Iobenguane I-123 Injection) or similar agents within the heart.
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) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------ | -------------------------------------------------------------------------------------------------------------------- |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/4/Picture/0 description: The image is a company logo for Spectrum Dynamics Medical. The logo features a geometric shape on the left, resembling a three-dimensional triangle with blue and white colors. To the right of the shape, the word "SPECTRUM" is written in large, bold, blue letters, followed by "DYNAMICS MEDICAL" in smaller blue letters. Below that, the text "A BIOSENSORS INTERNATIONAL GROUP COMPANY" is written in a smaller, lighter font.
510(K) SUMMARY
D-SPECT® Processing and Reviewing Workstation 510(k) Number K160120
| Applicant's Name: | Spectrum Dynamics Medical Ltd.
22 Bareket Street
Caesarea, Israel 3088900
Tel: +(972) 73-737-4500
Fax: +(972) 73 737-4501 |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary
Contact Person: | Yoram Levy, Qsite
31 Haavoda Street
Binyamina, Israel 30500
Tel +(972)4-638-8837; Fax +(972)4-638-0510
Yoram@qsitemed.com |
| Secondary
Contact Person: | Igor Naroditsky
Director QA/RA
22 Bareket Street
Caesarea, Israel 3088900
Tel: +(972)73-737-4386 Fax: +(972)73-737-4501
igorn@spectrum-dynamics.com |
| Trade Name: | D-SPECT® Processing and Reviewing Workstation |
| Common Name: | Nuclear Medicine Workstation |
| Preparation Date: | January 13, 2016 |
| Classification: | Name: Emission computed tomography system (Subsequent
Picture archiving and communication system)
Product Code: KPS (subsequent LLZ)
Regulation No: 21 CFR 892.1200 (subsequent 21CFR
892.2050)
Class: II
Panel: Radiology |
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Image /page/5/Picture/0 description: The image is a logo for Spectrum Dynamics Medical. The logo features a blue geometric shape on the left, followed by the text "SPECTRUM" in large, bold, blue letters. Below "SPECTRUM" is the text "DYNAMICS MEDICAL" in smaller, gray letters. Finally, below that is the text "A BIOSENSORS INTERNATIONAL GROUP COMPANY" in even smaller, gray letters.
Device Description:
D-SPECT® Processing and Reviewing Workstation is intended for acceptance, transfer, display, storage, and processing of images for detection of radioisotope tracer uptakes in the patient's body. The device using various processing modes supported by the various clinical applications and various features designed to enhance image quality. The emission computerized tomography data can be coupled with registered and/or fused CT/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. Visualization tools include segmentation, color coding, and polar maps. Analysis tools include Quantitative Perfusion SPECT (QPS), Quantitative Gated SPECT (QGS) and Quantitative Blood Pool Gated SPECT (QBS) measurements, Multi Gated Acquisition (MUGA) and Heart-to-Mediastinum activity ratio (H/M). It also includes reporting tools for formatting findings and user selected areas of interest. It is capable of processing and displaying the acquired information in traditional formats, as well as in three-dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs.
D-SPECT® Processing and Reviewing Workstation is based on Windows operating system. Due to special customer requirements and the clinical focus the D-SPECT® Processing and Reviewing Workstation can be configured in the same way as the predicate device with different combinations of Windows OS based software options and clinical applications which are intended to assist the physician in diagnosis and/or treatment planning. This includes commercially available post-processing software packages.
D-SPECT® Processing and Reviewing Workstation is a processing workstation primarily intended for, but not limited to
6
Image /page/6/Picture/0 description: The image contains the logo for Spectrum Dynamics Medical. The logo features a blue geometric shape on the left, resembling a three-dimensional triangle. To the right of the shape, the word "SPECTRUM" is written in large, bold, blue letters. Below "SPECTRUM" is the text "DYNAMICS MEDICAL" in a smaller font, and below that is the text "A BIOSENSORS INTERNATIONAL GROUP COMPANY".
cardiac applications. The workstation can be a part of the FDA cleared D-SPECT® Cardiac Scanner System (K110507) or integrated to a separate standalone post processing station. "SUMO" optional application enables visual evaluation and assessment of the sympathetic innervation system of the heart by quantification of uptake ratios between regions of interest, identifying discreet uptake areas within the heart of mIBG I-123 (AdreView™ Iobenguane I-123 Injection) or similar agents.
Indications for use:
The D-SPECT® Processing and Reviewing Workstation is intended for Processing, Reporting, Archiving, Display, Communication and Analysis of emission computerized tomography data using tools for imaging and automated review and quantification of Cardiac SPECT data.
The D-SPECT® Processing and Reviewing Workstation is intended to work with Spectrum Dynamics' D-SPECT® Cardiac Scanner System or as a separate standalone post processing workstation.
The D-SPECT® Processing and Reviewing Workstation is intended for use by the Nuclear Medicine (NM), Radiology or Electro Physiology Cardiology practitioners and referring physicians for display, processing, archiving, printing, reporting and networking of NMI data, including planar scans (Static, Dynamic, Multi-Gated) and tomographic three-dimensional scans (SPECT, Gated SPECT) acquired by gamma cameras. The system can run on a dedicated workstation or as part of Spectrum Dynamics' D-SPECT® Cardiac Scanner System. The NM data can be coupled with registered and/or fused X-Ray 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. "SUMO" optional application enables visual evaluation and assessment of the sympathetic innervation system of the heart by quantification of uptake ratios between regions of
7
Image /page/7/Picture/0 description: The image shows the logo for Spectrum Dynamics Medical. The logo consists of a blue triangular prism on the left and the company name on the right. The word "SPECTRUM" is in large, bold, blue letters, and the words "DYNAMICS MEDICAL" are in smaller, blue letters below it. Underneath the company name is the text "A BIOSENSORS INTERNATIONAL GROUP COMPANY".
interest, identifying discreet uptake areas of mIBG I-123 (AdreView™ Iobenguane I-123 Injection) or similar agents within the heart.
Predicate Devices:
The proposed D-SPECT® Processing and Reviewing Workstation is substantially equivalent to the following predicate device:
| Device Name | Manufacturer | 510k No | Date of Clearance |
|---|---|---|---|
| D-SPECT® Cardiac | |||
| Scanner System | Spectrum Dynamics | K110507 | July 13, 2011 |
The following are reference devices:
| Device Name | Manufacturer | 510k No | Date of Clearance |
|---|---|---|---|
| Xeleris 3.1 Processing | |||
| and Review Workstation | GE Healthcare | K130884 | March 21, 2013 |
| Emory Cardiac Toolbox | |||
| 3.2 | Syntermed | K130902 | June 14, 2014 |
The D-SPECT® Cardiac Scanner System (K110507), in particular it's processing and reviewing workstation, is the primary predicate device for the subject device. It is substantially equivalent in regard to its intended use, clinical indications and fundamental technology.
The GE Healthcare's Xeleris 3.1 Processing and Review Workstation (K130884) and the Emory Cardiac Toolbox 3.2 are reference devices in regard to the additional intended use, clinical indication for use and the technical parameters of the D-SPECT® Processing and Reviewing Workstation. It supports in particular the processing and reviewing workstation as a separate standalone workstation and the additional "SUMO" optional application.
Substantial Equivalence to Predicate and Reference Devices
The D-SPECT® Processing and Reviewing Workstation and its primary predicate device, the D-SPECT® Cardiac Scanner System (K110507) are
4 of 7 D-SPECT® Processing and Reviewing Workstation – 510k Submission Summary
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Image /page/8/Picture/0 description: The image shows the logo for Spectrum Dynamics Medical. The logo consists of a blue geometric shape on the left, followed by the text "SPECTRUM" in large, bold, blue letters. Below "SPECTRUM" is the text "DYNAMICS MEDICAL" in smaller, blue letters. Underneath that is the text "A BIOSENSORS INTERNATIONAL GROUP COMPANY" in even smaller, blue letters.
intended for the same use and have similar indications for use. Furthermore, the D-SPECT® Processing and Reviewing Workstation and its primary predicate device, the D-SPECT® Cardiac Scanner System (K110507), the processing station, have similar technological features.
The differences between the two devices are the separation of the processing and reviewing workstation as a separate standalone workstation and "SUMO" optional application as an additional indication.
The Xeleris 3.1 Processing and Review Workstation (K130884) and the Emory Cardiac Toolbox 3.2 (K130902) are reference devices, which support the additional intended use of D-SPECT® Processing and Reviewing Workstation as a separate standalone workstation for post image processing.
The Xeleris 3.1 Processing and Review Workstation (K130884) and the Emory Cardiac Toolbox 3.2 (K130902) are reference devices which support the additional "SUMO" optional application.
Any minor differences in the design do not raise any new questions of safety and effectiveness issues, as verified by performance testing.
Results of tests and validations, performed with the proposed D-SPECT® Processing and Reviewing Workstation demonstrates that it is as safe and effective as its primary predicate device, without raising any new safety and/or effectiveness concerns.
Therefore, the D-SPECT® Processing and Reviewing Workstation is substantially equivalent to its predicate devices.
Performance Standards:
D-SPECT® Processing and Reviewing Workstation complies with:
- ISO 62304 Medical device software- Software life cycle processes
- · ISO 14971 Medical Devices- Application of risk management to medical devices
- · ISO 15223-1 Medical Devices- Symbols to be used with medical device labels, labeling and information to be supplied- Part 1
5 of 7 D-SPECT® Processing and Reviewing Workstation - 510k Submission Summary
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Image /page/9/Picture/0 description: The image shows the logo for Spectrum Dynamics Medical. The logo features a blue geometric shape on the left, resembling a stylized cube or crystal. To the right of the shape, the word "SPECTRUM" is written in large, bold, blue letters, with "DYNAMICS MEDICAL" in smaller blue letters below it. Underneath that, the text "A BIOSENSORS INTERNATIONAL GROUP COMPANY" is written in a smaller font size.
- · IEC 60601-1-4 General requirements for safety Collateral Standard: Programmable electrical medical systems
- · IEEE Std 3333.2.1-2015 IEEE Recommended Practice for Three-Dimensional (3D) Medical Modeling
- · DICOM PS 3.1-3.18 standard Digital Imaging and Communications in Medicine (DICOM) Standard
Performance Bench Tests
Bench testing demonstrated that the D-SPECT® Processing and Reviewing Workstation is as safe and effective as the cleared predicate devices.
The performance tests were done in addition to the successful completion of verification and validation testing as required by Spectrum Dynamics Medical quality system (per 21CFR 820 Quality System Regulation and ISO 13485 standard). Engineering testing and standards compliance testing were successfully conducted and did not raise any new safety questions or identify any new risks.
To demonstrate and validate the safety, effectiveness and clinical use of the modified D-SPECT® Processing and Reviewing Workstation using SUMO application, Spectrum Dynamics performed a number of validation and verification tests including overall performance study using a simulated phantom and a dataset of subjects in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff, Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data -Premarket Notification [510(k)] Submissions.
The performance tests indicate that the D-SPECT® Processing and Reviewing Workstation meets the specification requirements.
10
Image /page/10/Picture/0 description: The image shows the logo for Spectrum Dynamics Medical. The logo consists of a blue triangular prism on the left, followed by the text "SPECTRUM" in large, bold, blue letters. Below "SPECTRUM" is the text "DYNAMICS MEDICAL" in smaller, lighter blue letters. Underneath that is the text "A BIOSENSORS INTERNATIONAL GROUP COMPANY" in even smaller, lighter blue letters, underlined by a thin gray line.
Summary of Pre-Clinical and clinical study
D-SPECT® Processing and Reviewing Workstation is a Processing Workstation primarily intended for, but not limited to cardiac applications. The system is intended for use by the Nuclear Medicine (NM), Radiology or Electro Physiology Cardiology practitioners, and referring physicians for display, processing, archiving, printing, reporting and networking of NMI data, including planar scans (Static, Dynamic, Multi-Gated) and tomographic three-dimensional scans (SPECT, Gated SPECT) acquired by gamma cameras.
The safety and efficacy of the D-SPECT® Cardiac Scanner System device has been well established in scientific research due to the comprehensive clinical studies, scientific research and published literature of SPECT devices using the same technology and with its predicate devices, Spectrum Dynamics Ltd. believes that animal and clinical studies are not required to determine the safety and efficacy of the device.