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510(k) Data Aggregation

    K Number
    K091928
    Device Name
    10 X 10 VISION
    Manufacturer
    BIOPTICS, INC.
    Date Cleared
    2010-06-16

    (351 days)

    Product Code
    MWP
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOPTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bioptics 10 X 10 VISION is a digital specimen radiography add-on upgrade to previously released cabinet x-ray systems. The 10 X 10 Vision is used for digital specimen radiography to provide rapid verification that the correct tissue has been excised during excisional or percutaneous biopsy. The 10 X 10 Vision is excluded from any use in in-vivo diagnostic or screening mammography applications.
    Device Description
    The 10 X 10 VISION will be marketed as a digital specimen radiography add-on upgrade for standard film-based cabinet x-ray systems. using high-performance, flat panel CMOS detector, and high-resolution Gd202S:Tb (Gadolinium Oxysulfide) scintillator technologies. Bioptics digital x-ray imagers are packaged in a thin (<14 mm) form factor similar to standard film cassette, include power supply, cables and needed mechanical accessories for convenient and cost-efficient upgrade of existing film-based cabinet x-ray systems. The x-ray imager assembly is installed permanently in the detector/cassette housing compartment or at the base of the host cabinet x-ray unit. The passive x-ray detection technology does not emit radiation and its low power (<5W) consumption does not require additional cooling. The 10 X 10 VISION employs the use of Bioptics Vision image acquisition software. The Bioptics Vision software handles digital x-ray image acquisition, calibration, image display, image analysis and manipulation, patient database, image archiving, and transmittal. Bioptics Vision software is the central part of this system. Bioptics Vision software is compliant with Digital Imaging and Communications in Medicine (DICOM) 3.0, and comes with DICOM Print, Store and Modality Work List (MWL).
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    K Number
    K091558
    Device Name
    BIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEM
    Manufacturer
    BIOPTICS, INC.
    Date Cleared
    2009-07-17

    (50 days)

    Product Code
    MWP
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOPTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BioVision Digital Specimen Radiography (DSR) System is a cabinet digital X-ray imaging system intended to generate and control X-rays for examination of various anatomical regions, and to provide rapid verification that the correct tissue has been excised during excisional or percutaneous biopsy. Performing the verification directly in the same biopsy procedure room enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls. This device is intended to be operated wherever the medical professionals deem appropriate, including a surgical suite or a room adjacent to a surgical suite.
    Device Description
    The BioVision Digital Specimen Radiography (DSR) System is a stand-alone cabinet digital X-ray imaging system to provide rapid verification that the correct tissue has been excised during percutaneous biopsy. Performing the verification directly in the same biopsy procedure room enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls. The BioVision Digital Specimen Radiography (DSR) System employs the use of Bioptics Vision image acquisition software. The Bioptics Vision software handles the digital X-ray image acquisition, calibration, image display, image analysis and manipulation, patient database, image archiving, and transmittal. Bioptics Vision software is the central part of this system. Bioptics Vision software is Digital Imaging and Communications in Medicine (DICOM) 3.0 compliant and comes with DICOM Print, Store and Modality Work List (MWL).
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    K Number
    K082432
    Device Name
    CORE VISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM
    Manufacturer
    BIOPTICS, INC.
    Date Cleared
    2008-11-21

    (91 days)

    Product Code
    MWP
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOPTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Core Vision Digital Specimen Radiography (DSR) System is a cabinet digital X-ray imaging system intended to generate and control X-rays for examination of various anatomical regions, and to provide rapid verification that the correct tissue has been excised during percutaneous biopsy. Performing the verification directly in the same biopsy procedure room enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls. This device is intended to be operated wherever the medical professionals deem appropriate, including a surgical suite or a room adjacent to a surgical suite.
    Device Description
    The Core Vision Digital Specimen Radiography (DSR) System is a stand-alone cabinet digital X-ray imaging system to provide rapid verification that the correct tissue has been excised during percutaneous biopsy. Performing the verification directly in the same biopsy procedure room enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls. The Core Vision Digital Specimen Radiography (DSR) System employs the use of Bioptics Vision image acquisition software. The Bioptics Vision software handles the digital X-ray image acquisition, calibration, image display, image analysis and manipulation, patient database, image archiving, and transmittal. Bioptics Vision software is the central part of this system. Bioptics Vision software is Digital Imaging and Communications in Medicine (DICOM) 3.0 compliant and comes with DICOM Print, Store and Modality Work List (MWL).
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    K Number
    K052433
    Device Name
    PIXARRAY 100 DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM
    Manufacturer
    BIOPTICS, INC.
    Date Cleared
    2005-10-18

    (42 days)

    Product Code
    MWP
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOPTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The piXarray 100 Digital Specimen Radiography (DSR) System is a cabinet digital Xray imaging system intended to generate and control X-rays for examination of various anatomical regions, and to provide rapid verification that the correct tissue has been excised during excisional or percutaneous biopsy. Performing the verification directly in the same biopsy procedure room enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls. This device is intended to be operated wherever the medical professionals deem appropriate, including a surgical suite or a room adjacent to a surgical suite.
    Device Description
    The piXarray 100 Digital Specimen Radiography (DSR) System is a standalone cabinet digital X-rav imaging system to provide rapid verification that the correct tissue has been excised during excisional or percutaneous biopsy. Performing the verification directly in the same biopsy procedure room enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls. The piXarray 100 Digital Specimen Radiography (DSR) System employs the use of Biopix image acquisition software. The Biopix software handles the digital X-ray image acquisition, calibration, image display, image analysis and manipulation, patient database, image archiving, and transmittal. Biopix software is the central part of this system. Biopix software is Digital Imaging and Communications in Medicine (DICOM) 3.0 compliant and comes with DICOM Print, Store and Modality Work List (MWL).
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