Search Filters

Search Results

Found 15 results

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?
    Product Code :

    KPT

    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.
    Ask a Question
    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?
    Product Code :

    KPT

    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.
    Ask a Question
    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?
    Product Code :

    KPT

    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.
    Ask a Question
    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?
    Product Code :

    KPT

    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.
    Ask a Question
    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?
    Product Code :

    KPT

    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.
    Ask a Question
    K Number
    K090296
    Device Name
    ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336
    Manufacturer
    BIODEX MEDICAL SYSTEMS, INC.
    Date Cleared
    2009-02-19

    (13 days)

    Product Code
    KPT
    Regulation Number
    892.1360
    Why did this record match?
    Product Code :

    KPT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Atomlab dose calibrators are used in Nuclear Medicine Departments, clinics and nuclear pharmacies for calibrating radioactive doses for administration to patients. The instrument is used to verify the radioactivity of a radionuclide before administration to the patient.
    Device Description
    The Atomlab dose calibrator is comprised of a display unit and one or more connected argon gas filled pressurized jonization chamber detector unit. The calibration for the dose calibrator is contained in the chamber has a callbration certificate with it when it is shipped. Any of the Atomlab 400 and 500 displays can be connected to the chamber and will work correctly with the chamber since the calibration is stored in the chamber.
    Ask a Question
    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?
    Product Code :

    KPT

    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.
    Ask a Question
    K Number
    K042746
    Device Name
    PET-DOSE
    Manufacturer
    COMECER S.R.L.
    Date Cleared
    2004-11-22

    (49 days)

    Product Code
    KPT
    Regulation Number
    892.1360
    Why did this record match?
    Product Code :

    KPT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PET-Dose is a radionuclide dose calibrator designed to measure the amount of radioactity in vials, syringes, and in any other user-defined geometry samples. It is intended to assay vials, syringes, and mainly capsules before administration to patients, by measuring the residual of radiopharmaceutical in vials, the activity of the injectable in syringes, the activity of capsules before they are administered to patients, etc. The best applications of PET-Dose are activity measurements of beta emitters used in PET diagnostics such as. 18F, 12N, 150, etc. PET-Dose is best fitted for use in nuclear medicine departments and, particularly, in PET centers.
    Device Description
    PET-Dose is a radionuclide dose calibrator designed to measure the amount of radioactity in vials, syringes, and in any other user-defined geometry samples.
    Ask a Question
    K Number
    K030066
    Device Name
    CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165
    Manufacturer
    NUCLEAR ASSOCIATES
    Date Cleared
    2003-08-29

    (234 days)

    Product Code
    KPT
    Regulation Number
    892.1360
    Why did this record match?
    Product Code :

    KPT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mark VI 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 Mark VI Dose Calibrator is designed to measure the amount of radioactive material in vials, syringes and capsules. Data related to the factory calibration is stored in the chamber. This standardizes the response of each ion chamber, allowing each chamber to report the same amount of electric current for the same radiation source. The isotopic calibration factors are stored in the control/readout unit. The ion chamber current is processed using the isotopic calibration factors stored in the control unit in order to determine the amount of radioactive material present.
    Ask a Question
    K Number
    K011493
    Device Name
    MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY
    Manufacturer
    MENTOR CORP.
    Date Cleared
    2002-10-01

    (504 days)

    Product Code
    KPT
    Regulation Number
    892.1360
    Why did this record match?
    Product Code :

    KPT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

    Page 1 of 2