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510(k) Data Aggregation

    K Number
    K182572
    Device Name
    InstaRISPACS / InstaZFP / InstaMobi v5.0
    Date Cleared
    2019-04-12

    (206 days)

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

    Meddiff Technologies Pvt. Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    InstaRISPACS / InstaZFP / InstaMobi is a software device (Enterprise Server, Diagnostic Workstation, Physician Zerofoot print Viewer and a Mobile Viewer) used for viewing and manipulating digital images (including mammography and data from various sources (including CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging sources) can be displayed, processed, stored and communicated across computer networks using this software. InstaPACS modules can be integrated with an institution's existing Hospital Information System (HIS) or Radiology Information System (RIS) based on the study of the System, providing seamless access to reports for fully-integrated electronic patient records. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA cleared monitor that offers at least 5 Megapixel resolution and meets other technical specifications reviewed and accepted by FDA. InstaRISPACS / InstaZFP / InstaMobi is not intended for diagnostic image review or diagnostic use on mobile devices.
    Device Description
    InstaRISPACS / InstaZFP / InstaMobi, is a software application used for viewing and manipulating medical images. Digital images and data from various sources (including CT. MR. US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or imaging sources) can be displayed, processed, stored and communicated across computer networks using this software. When viewing images, users can perform adjustments of window width and level, annotation and various image manipulations. - . InstaRISPACS, is a server-based application for use by Physicians, which comes with the Diagnostic Viewer. - InstaZFP, is a Zero Foot print viewer for use by Physicians to display images after ● fetching them from the InstaRISPACS server. - . InstaMobi, is a Mobile application (for iOS & Android), for use by Physicians to fetch images from InstaRISPACS and display them on the mobile device. In addition, InstaRISPACS, can be integrated with an institution's existing Hospital Information System or Radiology Information System (based on the study of the System), providing seamless access to reports for fully-integrated electronic patient records.
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    K Number
    K120718
    Device Name
    INSTAPACS/INSTARISPACS
    Date Cleared
    2012-04-19

    (42 days)

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

    MEDDIFF TECHNOLOGIES PVT. LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    InstaPACS™InstaRISPACS ™ is a software device (DICOM Gateway Application, Enterprise Server, and Workstation) used for viewing and manipulating digital medical images. Digital images (including mammography and data from various sources (including CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or imaging sources) can be displayed, processed, stored and communicated across computer networks using this software. InstaPACS™InstaRISPACS™ can be integrated with an institution's existing Hospital Information System (HIS) or Radiology Information System (RIS) based on the study of the System, providing seamless access to reports for fully-integrated electronic patient records. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
    Device Description
    InstaPACS™/InstaRISPACS™ is a software application used for viewing and manipulating medical images. Digital images and data from various sources (including CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or imaging sources) can be displayed, processed, stored and communicated across computer networks using this software. When viewing images, users can perform adjustments of window width and level, annotation, and various image manipulations. In addition, the device can be integrated with an institution's existing Hospital Information System or Radiology Information System (based on the study), providing seamless access to reports for fully-integrated electronic patient records. InstaPACS™/InstaRISPACS™ allows multiple centers or hospitals to send their images to a central server where Radiologists can view images over Web. It consists of following components: - . Central Server - runs the Web Server and Image Server and provide study and image data to doctors. The server includes a DICOM Gateway Application which is deployed at remote centers or hospitals. It receives images from modalities over LAN and uploads them to central server - WorkStation User at the client side can access the study list in the . browser. They can select the patient and download the images.
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