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510(k) Data Aggregation

    K Number
    K163668
    Device Name
    SUITESTENSA
    Manufacturer
    Date Cleared
    2017-06-23

    (178 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    EBIT srl

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SUITESTENSA is an integrated software system for the management and reporting of diagnostic-instrumental procedures in Cardiology and Radiology departments. It is intended to support and assist trained professionals in the diagnostic process, through the acquisition, storage, viewing, processing and reporting of cardiology imaging studies and ECG traces. SUITESTENSA also allows transfer of images to CD/DVD. SUITESTENSA may be used also for the display, manipulation, and interpretation of lossless compressed or noncompressed mammography images that have been received in the DICOM For Presentation format and displayed on FDA cleared, DICOM compatible displays for mammography. SUITESTENSA is intended to be used by qualified professionals, i.e. doctors (radiologists, etc.), ward technicians, paramedics, administrative personnel, specialist ward doctors.
    Device Description
    SUITESTENSA Software is a RIS/CIS/PACS software suite managing the entire clinical workflow of a Radiology and Cardiology Department through the following software modules being part of the Software Suite: - SUITESTENSA PACS Archiving Software System - SUITESTENSA Review Diagnostic Reporting Software - SUITESTENSA RIS – Radiology Information System - SUITESTENSA CIS Cardiology Information System - SUITESTENSA MPS Media Production Software System - SUITESTENSA QC - Integration Process Quality Control SUITESTENSA natively integrates SUITESTENSA RIS/CIS and may integrate with any other third party RIS/CIS software that has HL7 interface capabilities.
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