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510(k) Data Aggregation

    K Number
    K983945
    Device Name
    CORTEX DERMASCAN C ULTRASONIC SYSTEM
    Manufacturer
    CORTEX TECHNOLOGY APS
    Date Cleared
    1999-03-17

    (132 days)

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

    CORTEX TECHNOLOGY APS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DermaScan C is an ultrasonic scanning system intended to be used to visualize the layers of the skin, including blood vessels, and to make approximate measurements of dimensions in the layers of the skin and blood vessels, by ultrasonic means.
    Device Description
    The DermaScan C provides the following visualization modes: a. 2-dimensional B-scan, displayed in real time b. M-scan, displayed in real time c. A-scan, as a "frozen" image derived from a B-scan line.
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    K Number
    K982280
    Device Name
    CRYOPRO MAXI AND CRYOPRO MINI
    Manufacturer
    CORTEX TECHNOLOGY APS
    Date Cleared
    1998-11-25

    (148 days)

    Product Code
    GEH
    Regulation Number
    878.4350
    Why did this record match?
    Applicant Name (Manufacturer) :

    CORTEX TECHNOLOGY APS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CryoPro® Mini and CryoPro Maxi units are intended to be used within the fields of dermatology and plastic surgery for the treatment of cryoresponsive benign, premalignant and malignant tumors such as skin tags, verrucae, actinic keratoses and basal cell carcinoma.
    Device Description
    The CryoPro® Mini consists of a 0.35 L stainless steel vacuum insulated, stainless steel flask equipped with a stainless steel top which holds a pressure relief valve and a dispensing valve for dispensing liquid nitrogen. The dispensing valve body is made of stainless steel with a brass valve stem and sealed with a Teflon gasket. The dispensing valve may be mounted with spray nozzles or closed contact probes of varying sizes depending on the size and nature of the area to be treated. The CryoPro® Maxi provides a 0.5 L stainless steel vacuum insulated flask and is otherwise identical to the CryoPro® Mini unit.
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