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510(k) Data Aggregation

    K Number
    K083377
    Device Name
    ACCUPEN
    Manufacturer
    ACCUTOME ULTRASOUND, INC.
    Date Cleared
    2009-07-27

    (255 days)

    Product Code
    HKX, HKY
    Regulation Number
    886.1930
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACCUTOME ULTRASOUND, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The indications for use include measuring intraocular pressure for suspected glaucoma or when an increased intraocular pressure is suspected.
    Device Description
    Not Found
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    K Number
    K070943
    Device Name
    B-SCAN PLUS
    Manufacturer
    ACCUTOME ULTRASOUND, INC.
    Date Cleared
    2007-04-19

    (15 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACCUTOME ULTRASOUND, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The instrument is used for imaging the internal structure of the eye including the opaque media and posterior pathology for the purpose of diagnosing pathological or traumatic conditions in the eye.
    Device Description
    The B-Scan Plus device is designed as an ultrasound B- Scan which uses pulsed echo ultrasound to image the internal structure of the eye. It utilizes an eye-contact probe to generate and receive the ultrasound pulses, and provides graphic display of returning pulse echoes to image these structures.
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    K Number
    K042752
    Device Name
    ACCUPACH V
    Manufacturer
    ACCUTOME ULTRASOUND, INC.
    Date Cleared
    2004-11-10

    (37 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACCUTOME ULTRASOUND, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The instrument is used for measuring the corneal thickness of the eye, and calculating a corrected intraocular pressure based on those measurements.
    Device Description
    The AccuPach V device is designed as an ultrasound pachymeter which uses pulsed echo ultrasound to measure the corneal thickness of the eye. It utilizes an eye-contact probe to generate and receive the ultrasound pulses, and provides a numeric display of returning pulse echoes to indicate the thickness of the cornea.
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