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510(k) Data Aggregation

    K Number
    K142325
    Device Name
    Veenstra Instruments VDC-506 Dose Calibrator
    Manufacturer
    Comecer Netherlands b.v.
    Date Cleared
    2014-09-18

    (29 days)

    Product Code
    KPT
    Regulation Number
    892.1360
    Why did this record match?
    Applicant Name (Manufacturer) :

    Comecer Netherlands b.v.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Veenstra Instruments VDC-506 Dose Calibrator is designed to measure the amount of radioactive material in vials, syringes and capsules. It is used to measure the amount of activity used to prepare radiopharmaceutical kits, measure the activity in syringes of radiopharmaceuticals prior to injection and to quantify the activity remaining in the syringe following injection. It is indicated for use in the preparation of radiopharmaceuticals and verification of the activity prior to patient administration.
    Device Description
    The Veenstra Instruments VDC-506 Dose Calibrator (VDC-506) is a software application installed on a personal computer (PC) running Windows XP, and is used in conjunction with the Veenstra Instruments VIK-202 ionization chamber (VIK-202) to measure the radioactive strength of radioactive material in vials, syringes and ampoules placed inside the ionization chamber. The VDC-506 software, in conjunction with the PC, serves as the control mechanism and display for the VIK-202 ionization chamber. The PC on which the VDC-506 software is installed is connected to the VIK-202 ionization chamber using a RS-232 cable. It is recommended that the PC includes a touchscreen display for convenient navigation within the software; however, a touchscreen is not necessary.
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