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510(k) Data Aggregation

    K Number
    K050088
    Device Name
    QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER
    Manufacturer
    NEOPROBE CORP.
    Date Cleared
    2005-02-08

    (26 days)

    Product Code
    DPW
    Regulation Number
    870.2100
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEOPROBE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quantix/OR Blood Flow Monitor is intended for invasive and noninvasive diagnostic blood flow measurements.
    Device Description
    The Quantix/OR™ Blood Flow Monitor with Flexible Probe and Vessel Stabilizer is a dualbeam, angle independent, pulse-wave Doppler ultrasound system for the invasive and noninvasive blood vessel flow measurements. In addition to the conventional Doppler (blood flow velocity) measurements, the Quantix/ORTM Flexible Probe technology utilizes ultrasound Doppler methods to obtain real-time measurements according to the definition of blood flow volume to target blood vessels. By definition, blood flow is the product of velocity cross-sectional area. In other words, the volume blood flow is calculated by deriving flow velocity from the Doppler shift frequency using the basic standard formula and then multiplying the velocity by the cross-sectional area of the blood vessel.
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    K Number
    K971167
    Device Name
    NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES
    Manufacturer
    NEOPROBE CORP.
    Date Cleared
    1997-06-26

    (87 days)

    Product Code
    IZD
    Regulation Number
    892.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEOPROBE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Neoprobe® Model 1500 Portable Radioisotope Detector is an electronic device intended to detect and quantify gamma radiation. It is indicated for external and intraoperative detection of radioactivity in body tissues or organs, such as bowel, bone, lymphatics, and red blood cells, where radiopharmaceuticals are administered.
    Device Description
    The Neoprobe® Model 1500 Portable Radioisotope Detector ("Model 1500") consists of (1) a microcomputer-based control unit: (2) a 12 mm collimated detector probe tip, a 12 mm non-collimated detector probe tip, and a 19 mm noncollimated probe tip, all of which are reusable, steam sterilizable and contain a cadmium zinc telluride crystal gamma ray detector; (3) a disposable sterile probe handle with an attached polypropylene cable; (4) a check source disk containing a known quantity of 1201; and (5) a chrome-plated Teflon-lined lead noise adjustment fixture used for periodic verification that the system continues to meet factory calibration readings.
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    K Number
    K962319
    Device Name
    NEOPROBE 1000 GEN 1C PORTABLE RADIOISOTOPE DETECTOR & ACCESSORIES
    Manufacturer
    NEOPROBE CORP.
    Date Cleared
    1996-09-13

    (88 days)

    Product Code
    IZD
    Regulation Number
    892.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEOPROBE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Neoprobe Model 1000 GEN 1C Portable Radioisotope Detector is an electronic device intended to detect and quantify gamma radiation. The GEN 1C in indicated for external and intraoperative detection of radioactivity in body tissues or organs in medical procedures where gamma emitting isotopes are administered.
    Device Description
    The Neoprobe Model 1000 GEN 1C Portable Radioisotope Detector ("Model 1000") consists of a microcomputer-based control unit, a cadmium zinc telluride gamma ray detector probe, a cable used to connect the probe to the control unit, a check source containing a known quantity of 129 I, and a chrome-plated Teflon-lined lead noise adjustment fixture used for periodic verification that the system continues to meet factory calibration readings. The detector probe is available in two sizes: (1) a detector probe with a 19 mm external diameter and a detector diameter of 15 mm; and (2) a detector probe with an 11 mm external diameter and a detector diameter of 7 mm. Optional accessories include a detector probe collimator and a detector probe shield.
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