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510(k) Data Aggregation

    K Number
    K183142
    Device Name
    PathVisionXL
    Manufacturer
    Faxitron Bioptics LLC
    Date Cleared
    2019-03-14

    (121 days)

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

    Faxitron Bioptics LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PathVisionXL is a Cabinet x-ray system that is used to provide film and/or digital x-ray images of harvested specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure. Doing the verification directly in the same room or nearby 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.
    Device Description
    The PathVisionXL is specially designed for high detail radiographic imaging of surgically excised medical specimens. It is a fully shielded Cabinet X- ray System that has been designed to comply with 21 CFR 1020.40. The larger (XL) cabinet allows up to 10.0 times geometric magnification of excised specimens with minimal geometric distortion through the use of a focal spot size that is less than 15 microns. With optimized cabinet geometry and the superior contrast available from the low kV capability, the PathVisionXL provides enhanced image performance. It is designed to acquire a large high resolution digital images up to 43 x 43 cm in size, through the use an integrated digital X-Ray detector and Faxitron Vision software. The Faxitron Software supports the DICOM Store, Print and Modality Worklist services.
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    K Number
    K173309
    Device Name
    Faxitron VisionCT
    Manufacturer
    Faxitron Bioptics Llc
    Date Cleared
    2018-05-09

    (203 days)

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

    Faxitron Bioptics Llc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Faxitron VisionCT is a Cabinet x-ray system that is used to provide two and three dimensional digital x-ray images of harvested specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure. Doing the verification directly in the same room or nearby 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.
    Device Description
    The Faxitron VisionCT is specially designed for high detail radiographic imaging of surgically excised medical specimens. It is a fully shielded Cabinet X- ray System that has been designed to comply with 21 CFR 1020.40. It allows up to 4.0 times geometric magnification of excised specimens with minimal geometric distortion through the use of a focal spot size that is less than 15 microns. With optimized cabinet geometry and the superior contrast available from the low kV capability. the VisionCT provides enhanced image performance. It is configured to acquire high resolution digital images up to 15 x 15 cm in size, through the use an integrated detector and Faxitron Vision Specimen Radiography software. The Faxitron Software supports the DICOM Store, Print and Modality Worklist services.
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    K Number
    K170786
    Device Name
    Faxitron Bioptics Speciemen Radiography System
    Manufacturer
    Faxitron Bioptics LLC
    Date Cleared
    2017-07-18

    (124 days)

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

    Faxitron Bioptics LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VersaVision is a Cabinet x-ray system that is used to provide film and/or digital x-ray images of harvested specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure. Doing the verification directly in the same room or nearby 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.
    Device Description
    The Faxitron VersaVision Specimen Radiography System is a Cabinet X-ray System specifically designed to provide high detail radiographic imaging of surgically excised medical specimens. The exceptionally high magnification capability (up to 8X) from the <15 micron focal spot with optimized cabinet geometry and the superior contrast available from the low kV capability provides enhanced film and/or digital imaging performance. This device supports radiographic film sizes up to 15 x 24 cm and can be configured to acquire high resolution, DICOM compliant, digital x-ray images up to 15 x 24 cm in size through the use an integrated detector and Faxitron Vision Specimen Radiography software.
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    K Number
    K153583
    Device Name
    BioVision Plus
    Manufacturer
    FAXITRON BIOPTICS LLC
    Date Cleared
    2016-04-01

    (108 days)

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

    FAXITRON BIOPTICS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BioVision (Plus/ +)Digital Specimen Radiography (DSR) System is a cabinet digital X-ray imaging system intended to generate and control X-rays for examination of harvested specimens from various anatomical regions, and to provide rapid verification that the correct tissue has been excised. 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(Plus) Digital Specimen Radiography (DSR) System is a standalone cabinet digital X-ray imaging system designed to provide rapid verification that the correct tissue has been excised. Performing the verification directly in the same 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(Plus) Digital Specimen Radiography (DSR) System employs the use of Faxitron Bioptics Vision image acquisition software. The Vision software handles the digital X-ray image acquisition, calibration, image display, image analysis and manipulation, patient database, image archiving, and transmittal.
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    K Number
    K122428
    Device Name
    FAXITRON SPECIEN RADIOGRAPHY SYSTEM
    Manufacturer
    FAXITRON BIOPTICS LLC
    Date Cleared
    2012-09-25

    (47 days)

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

    FAXITRON BIOPTICS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PathVision is a Cabinet x-ray system that is used to provide film and/or digital x-ray images of harvested specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure. Doing the verification directly in the same room or nearby 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.
    Device Description
    The Faxitron PathVision Specimen Radiography System is a Cabinet X-ray System specifically designed to provide high detail radiographic imaging of surgically excised medical specimens. The exceptionally high magnification capability (up to 6X) from the 0.02 mm focal spot with optimized cabinet geometry and the superior contrast available from the low kV capability provides enhanced film and/or digital imaging performance. This device supports radiographic film sizes up to 35 x 35 cm and can be configured to acquire high resolution, DICOM compliant, digital x-ray images up to 23 x 29 cm in size through the use an integrated camera and Faxitron Specimen Radiography software.
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