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510(k) Data Aggregation

    K Number
    K192199
    Device Name
    CRC PC Smart Chamber K1
    Manufacturer
    Capintec, Inc.
    Date Cleared
    2019-09-12

    (30 days)

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

    Capintec, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CRC PC Smart Chamber K1 is intended to be used by qualified nuclear medicine technologists, nuclear medicine physicians, and radiopharmacists to measure radiopharmaceuticals, including high energy beta and gamma emitters for diagnostic applications. The CRC PC Smart Chamber K1 is intended to be used only with the TEMA Karls 100 radiopharmaceutical dose administration system.
    Device Description
    The Capintec CRC PC Smart Family of dose calibrators are sealed, pressurized reentrant well style ionization chambers which use a networked PC as the user interface. The CRC PC Smart Chamber K1 is modified CRC PC Smart Chamber, which has been shortened in height to fit into the Karl 100 Dose Administration System, which is manufactured by TEMA.
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    K Number
    K162394
    Device Name
    CRC-77tHR
    Manufacturer
    Capintec, Inc.
    Date Cleared
    2017-03-08

    (194 days)

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

    Capintec, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CRC-77tHR is intended to be used by qualified radiochemists, radiation physicists, or other appropriately trained personnel in isotope production sites to measure a wide range of measure a wide range of high activity radiopharmaceuticals and radioactive materials, including high energy beta and gamma emitters. The device is not intended for use with brachytherapy sources. This device is also used in numerous research applications for measurement of high activity levels of radioactive materials.
    Device Description
    The Capintec CRC-77tHR is dose calibrator which uses a touch screen user interface and sealed reentrant well chamber as the detector. The gas fill pressure has been lowered in order to extend the maximum activity range for isotope manufacturing and radiopharmaceutical production environments.
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    K Number
    K141413
    Device Name
    CRC PC WITH SMART CHAMBER
    Manufacturer
    CAPINTEC, INC.
    Date Cleared
    2014-06-27

    (29 days)

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

    CAPINTEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CRC PC Smart Chamber series is intended to be used by qualified nuclear medicine technologists, nuclear medicine physicians, and radiopharmacists to measure a wide range of radiopharmaceuticals and radioactive materials, including high energy befa and gamma emitters for diagnostic and therapeutic applications. It is also designed for use by trained medical physicists for diagnostic and therapeutic applications including measurement of the output of most radioactive brachytherapy sources, including LDR, HDR, and IVBT sources. All brachytherapy sources must be measured in the appropriate source holder. This device is also used in numerous research applications for measurement of radioactive materials.
    Device Description
    Capintec's CRC PC Smart Chamber series dose calibrators are designed for measurement of radioactive materials used in nuclear medicine, therapy, and research applications. The unit is intended for use by trained nuclear medicine technologists, nuclear medicine physicians, radiopharmacists, or medical physicists for diagnostic and therapeutic applications. The CRC PC series has the same principles of operation, same basic functionality, and same detector technology as the predicate device, CRC 55t series. The basic detection, measurement process, design concepts, calculations, and response remain the same as the predicate device. There are no differences in intended use or effectiveness. The CPC PC Smart Chamber replaces the touchscreen user interface of the predicate device with a laptop or network PC.
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    K Number
    K101452
    Device Name
    CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW
    Manufacturer
    CAPINTEC, INC.
    Date Cleared
    2010-08-09

    (76 days)

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

    CAPINTEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CRC 55t series, which includes the standard 55tR dose calibrator, reduced pressure chamber (CRC 55tPET) and well counter (CRC55tW), is intended to be used by qualified nuclear medicine technologists, nuclear medicine physicians, and radiopharmacists to measure a wide range of radiopharmaceuticals and radioactive materials, including high energy beta and gamma emitters for diagnostic, therapeutic, or in vitro laboratory tests. It is also designed for use by trained medical physicists to measure the output of most radioactive brachytherapy sources, including LDR, HDR, and IVBT sources. All brachytherapy sources must be measured in the appropriate source holder. The well counter is designed for measurement of low activity radioactive sources or solutions in vitro laboratory test applications. This device is also used in numerous research applications for measurement of radioactive materials.
    Device Description
    Capintec's CRC 55t series dose calibrators are designed for measurement of radioactive materials used in nuclear medicine, therapy, laboratory tests, and research applications. The unit is intended for use by trained nuclear medicine technologists, nuclear medicine physicians, radiopharmacists, or medical physicists for diagnostic, in vitro, and therapeutic applications. The CRC 55t series uses the same principles of operation, same basic electronic circuitry, and same detector technology as the predicated device, CRC 25 series. The basic detection, measurement process, design concepts, functionality, calculations, algorithms, and response remain the same as the predicate device. There are no differences in intended use or effectiveness. The 55t replaces the traditional keypad interface with a larger color touch screen display. The CRC 55t provides enhanced user interface features associated with newer touch screen technology. In addition, the CRC 55t provides an expanded MCA for isotope identification. The predicate device contains 6 fixed channels which provides only preliminary information. The CRC 55t includes a 256 channel MCA which permits spectral identification.
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    K Number
    K071396
    Device Name
    CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS
    Manufacturer
    CAPINTEC, INC.
    Date Cleared
    2007-06-28

    (38 days)

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

    CAPINTEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CRC 25R dose calibrator, which includes optional well counter (CRC 25W) or reduced pressure chamber (CRC 25PET), is intended to be used by qualified nuclear medicine technologists to measure a wide range radiopharmaceuticals, including high energy beta and gamma emitters. It is also designed for use by trained medical physicists to measure the output of most radioactive brachytherapy sources, including HDR. LDR and IVBT sources. All brachytherapy sources must be measured in the appropriate source holder. The well counter is designed for measurement of low activity radioactive sources or solutions, including laboratory test applications. This device is used in numerous research applications for measurement of radioactive materials.
    Device Description
    The Capintec CRC 25 series is a reduced feature version of the CRC 15Ultra. The CRC 25 series uses the same basic hardware, and same detectors as the CRC 15 Ultra, but does not provide the ability to use multiple chambers, nor does the CRC 25 support the addition of a beta counter. The basic detection, measurement process, design concepts, functionality, calculations, algorithms, and response remain the same as the predicate device.
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    K Number
    K052595
    Device Name
    CRC 15ULTRA
    Manufacturer
    CAPINTEC, INC.
    Date Cleared
    2005-11-08

    (48 days)

    Product Code
    JAQ, KPT
    Regulation Number
    892.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAPINTEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CRC 15Ultra multiple chamber dose calibrator, which includes optional beta counter and well counter, is intended to be used by qualified nuclear medicine technologists to measure a wide range radiopharmaceuticals, including high mergy beta and gamma emitters. It is also designed for use by trained medical physicists to measure the output of most radioactive brachytherapy sources, including HDR, LDR and IVBT sources. All brachytherapy sources must be measured in the appropriate source holder. The well counter is designed for measurement of low activity radioactive sources or solutions, including laboratory test applications. This device is used in numerous research applications for measurement of radioactive materials.
    Device Description
    The Capintec CRC 15Ultra is a multiple detector system, which may include up to eight sealed pressurized re-entrant well chambers, plus a high energy beta counter, and a well counter. The CRC 15Ultra combines the features of several well established Capintec models: CRC 35R, CRC 15R, Beta Counter, and Caprac R Counter into one unit with flexible configurations which are field upgradeable. The 15Ultra incorporates enhanced electronic circuitry and faster microprocessor capabilities, which extends it capability to network eight ionization chambers, as did the CRC 35R. However, the CRC 15Ultra can also add the detector assembly from the Beta C Counter, or the detector assembly from the Caprac R Well Counter, to the same universal readout. The basic design concepts, functionality, calculations, algorithms, and response are the same.
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    K Number
    K030175
    Device Name
    2 BASIC
    Manufacturer
    CAPINTEC, INC.
    Date Cleared
    2003-04-17

    (90 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAPINTEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 2 Basic is intended to be used by trained medical physicist to measure the radiation output from radiation therapy machines for verification of patient treatment plan, quality assurance, or beam characteristics. It is not intended to function as a primary calibration device. The 2 Basic can be used in direct surface contact with patients or in a phantom material. The 2 Basic is a solid state diode detector system coupled with a precision electrometer and PC for radiation measurement, data storage and display. It is intended to be used by trained medical physicists for the measurement of radiation output from radiation therapy treatment machines. The 2 Basic can be used with direct patient contact for entrance skin measurements, or in air, water, or other suitable phantoms materials for beam output measurements. Measurement data is used to verify and document the beam characteristics of radiation therapy treatment machines for quality assurance programs and to very therapeutic doses delivered to patients during treatments.
    Device Description
    The Capintec 2 Basic system consists of 2 diode detectors permanently attached to a precision electrometer and application software. The detectors are solid state silicon diodes with a hemispherical shape optimized for direct patient contact. They provide high sensitivity, excellent linearity, and uniform output vs. gantry angle. The diodes are completely water resistant and enclosed in biocompatible molded epoxy. The high precision electrometer measures the current from the detector and converts the value into a displayed dose and provides automatic zero compensation. Application software controls the system and stores measurement data for each detector, and associated beam parameters such as energy, MU, and patient demographic data. Data can be stored on the PC or printed for hard copy record. Customer must supply a UL recognized PC to be used with application software.
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    K Number
    K020150
    Device Name
    CRC-15BT
    Manufacturer
    CAPINTEC, INC.
    Date Cleared
    2002-08-02

    (198 days)

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

    CAPINTEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CRC 15BT dose calibrator is intended to be used by trained medical physicists, or qualified technologists to measure the activity or output of radioactive brachytherapy sources, including HDR, LDR and IVBT sources.
    Device Description
    The CRC 15BT dose calibrator is a well type ionization chamber specifically designed to accurately and rapidly measure all types of brachytherapy sources with appropriate calibration and source positioning device. The ionization chamber is connected to a readout, which converts measured current into a displayed value in units of either Ci (activity) or U (air kerma strength). The unit is sealed and pressurized with UPC Argon. which improves sensitivity and eliminates the need for temperature and pressure corrections.
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    K Number
    K982448
    Device Name
    CARDIOLIGHT
    Manufacturer
    CAPINTEC, INC.
    Date Cleared
    1999-06-11

    (331 days)

    Product Code
    DSH
    Regulation Number
    870.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAPINTEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MedSet Cardiolight system is intended to be used by trained ECG technicians with analysis and interpretation by cardiologists for the measurement and analysis of electrocardiogram signals on ambulatory patients as an aid to the diagnosis of heart disease.
    Device Description
    The MedSet Cardiolight System is a real time ambulatory ECG recording and analysis system for a recording period of up to 24 hours. The stored data is transferred to a PC for graphical display of the results as an aid to the medical diagnosis of heart disease by a trained cardiologist.
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    K Number
    K980402
    Device Name
    CAPINTEC MODEL 292 ELECTROMETER
    Manufacturer
    CAPINTEC, INC.
    Date Cleared
    1998-04-24

    (81 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAPINTEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THE CAPINTEC 292 ELECTROMETER IS INTENDED TO BE USED BY TRAINED MEDICAL PHYSICISTS OR QUALIFIED RADIATION THERAPY TECHNOLOGISTS TO PERFORM QUALITY ASSURANCE CHECKS AND MEASUREMENTS ON THE OUTPUT FROM THERAPEUTIC X-RAY MACHINES OR TELETHERAPY UNITS. WITH THE ADDITION OF AN OPTIONAL CAPINTEC CRC DOSE CALIBRATOR CHAMBER, THE 292 MAY ALSO BE USED BY TRAINED MEDICAL PAYSICISTS OR QUALIFIED TECHNOLOGISTS TO MEASURE RADIOACTIVE SOURCES USED FOR THERAPEUTIC OR DIAGNOSTIC TREATMENT.
    Device Description
    The 292 is a precise and accurate software controlled low impedance electrometer with four measurement ranges, adjustable + bias voltage which can act as a dose or dose rate meter.
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