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510(k) Data Aggregation

    K Number
    K111694
    Device Name
    ASTRA
    Manufacturer
    CANDELIS, INC.
    Date Cleared
    2011-09-15

    (91 days)

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

    CANDELIS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ASTRA is software image management intended to receive, process, review, display, print and archive medical images and data from imaging modalities (e.g., CR and DR), Images and data can be stored, communicated, and displayed within the system or across computer systems. ASTRA is comprised with three configurations depending upon the requirements of the user and desired options: ASTRA Plus , ASTRA Lite, and ASTRA Mobile. ASTRA runs on a PC workstation, iPad, or iPhone and may be interfaced with verified and validated image acquisition devices from Candelis or other PACS systems. Diagnosis is not performed by the software but by Radiologists, Clinicians or referring Physicians. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants. ASTRA Plus is used to: - share reports and studies with other ASTRA peers . - review reports and studies . - . download and save reports - send reports to local EMR, EHR, RIS, HIS or PACS systems (HL7 send) . - . route studies to PACS, Workstations, or other ASTRA peers ASTRA Lite is used to: - share reports and studies with other ASTRA peers . - . review reports and studies - download and save reports . - send reports to local EMR, EHR, RIS, HIS or PACS systems (HL7 send) . ASTRA Mobile is used to: - share reports with other ASTRA peers . - review reports . - . download and save reports - . send reports to local EMR, EHR, RIS, HIS or PACS systems (HL7 send) Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed Mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meets other technical specifications reviewed and accepted by FDA.
    Device Description
    ASTRA is a web-enabled software application that provides image processing and viewing tools and access to studies and reports from a Local Area Network. Wide Area Network, remote workstation, personal computer, or an iPhone, or iPad via a Virtual Private Network connection. Diagnosis is not performed by the software but by Radiologists, Clinicians or referring Physicians. The software application conforms to the DICOM 3.0 standard to allow interoperability with other DICOM compliant systems.
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    K Number
    K092949
    Device Name
    IMAGEGRID RADIOLOGY VIEWER SYSTEM
    Manufacturer
    CANDELIS, INC.
    Date Cleared
    2009-10-08

    (14 days)

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

    CANDELIS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ImageGrid Radiology Viewer System™ is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, and displayed within the system or across computer networks at distributed locations. Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed Mammographic images and digitized film screen images must not be reviewed for primary image interpretations. 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. Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians as an adjunctive to standard radiology practices for diagnosis. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.
    Device Description
    ImageGrid Radiology Viewer System™ is a client/server software application that is designed to be used with the ImageGrid PACS device or as an independent service. The ImageGrid Radiology Viewer System™ can query, retrieve, and display medical images that it retrieves from a DICOM SCP. The device is a client/server software service that permits concurrent access to the ImageGrid PACS' medical images.
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    K Number
    K080333
    Device Name
    IMAGEGRID
    Manufacturer
    CANDELIS, INC.
    Date Cleared
    2008-02-22

    (15 days)

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

    CANDELIS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ImageGrid™ is a software device and server that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). ImageGrid™ is a PACS solution, including: ImageGrid Web Viewer, ImageGrid OrderEntry, ImageGrid RiS, and ImageGrid Mammography Web Viewer. Images (including mammography) and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. 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
    ImageGrid Web Viewer is a client/server software application and server that is designed to be used with the ImageGrid PACS device or as an independent service. The ImageGrid Web Viewer can query, retrieve, and display medical images that it retrieves from a DICOM SCP. The ImageGrid Web Viewer is a client/server software service that permits concurrent access to the ImageGrid PACS' medical images. ImageGrid™ can be integrated with an institutions HIS or RIS for an integrated electronic patient record. ImageGrid™ is a software device and server that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). ImageGrid™ is a PACS solution, including: ImageGrid Web Viewer, ImageGrid OrderEntry, ImageGrid RIS, and ImageGrid Mammography Web Viewer. Images (including mammography) and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. 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.
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