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510(k) Data Aggregation

    K Number
    K083035
    Device Name
    DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM
    Manufacturer
    SICEL TECHNOLOGIES, INC.
    Date Cleared
    2008-11-13

    (30 days)

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

    SICEL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended Use: The DVS (Dose Verification System) is intended for use in radiation therapy to verify treatment planning and radiation dose to tissue and organs in or near the irradiated areas of a patient. Indications for Use: The DVS system is specifically indicated for breast and prostate cancer to measure photon beam therapy and as an adjunct to treatment planning to permit measurement of the in vivo radiation dose received at the tumor periphery, tumor bed and/or surrounding normal tissues for validation of the prescribed dose.
    Device Description
    The DVS, Dose Verification System consists of four sub-systems: the DVS Implantable Dosimeter for measuring radiation dose in vivo, the DVS Insertion Tool for implanting the dosimeter during percutaneous procedures, the DVS Reader System (Wand and Base Station) for powering the dosimeter and providing a user interface when taking dose measurements, and the DVS Data System (Plan and Review Software and Dosimetery Database) for storing and reporting patient data and for storing dosimeter information. The dosimeters use a MOSFET, Metal Oxide Semiconductor Field Effect Transistor, as a sensing mechanism. The dosimeter is factory calibrated and powered by the Reader Wand utilizing electromagnetic energy. The dosimeter contains a transmitter, to transmit threshold voltage readings to the reader. It is radioopaque and thus registers on computed tomography scans as a point of interest whereby a point dose may be determined. Patients are implanted prior to radiotherapy. Information on the patient's therapy, dose planning, point dose at the dosimeter, dosimeter serial number and calibration files are entered into the Plan and Review software and stored in the Dosimetry Database. At each therapy fraction the dosimeter is read pre- and post-therapy using the Reader Wand and Base Station. This translates into a daily fractional dose. The patient's daily and cumulative dose may be reviewed via the Plan and Review software. Because the Plan and Review software and Dosimetry Database are designed to be stored on a server, multiple users may be logged into the system at any one time. Reports on the patient's daily and cumulative dose history may be printed using the Plan and Review software.
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    K Number
    K081859
    Device Name
    MODIFICATION TO ONEDOSE PATIENT DOSIMETRY SYSTEM
    Manufacturer
    SICEL TECHNOLOGIES, INC.
    Date Cleared
    2008-08-04

    (34 days)

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

    SICEL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OneDose Patient Dosimetry System is intended to measure a patient's dose during radiotherapy application.
    Device Description
    The OneDose Patient Dosimetry System consists of the following components and accessories: (1) disposable, single use, pre-calibrated radiation dosiments, (2) a hand held, battery powered reader, (3) a reader calibration test strip and (4) reader download software. The dosimeters use a MOSFET, metal oxide semiconductor field effect transistor as a sensing mechanism. The dosimeters are inserted into the Reader and zeroed, then positioned onto a patient. The dosimeters are small and have no wires. They have a medical grade adhesive and liner on the back. The liner is removed and the adhesive side of the dosimeter is adhered to the patient. Following radiotherapy, the dosimeters are removed from the patient, re-inserted into the Reader, and the patient's dose is read and reported by the Reader. The patient's records are stored on the dosimeter for future reference and in the Reader's memory.
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    K Number
    K080004
    Device Name
    DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM
    Manufacturer
    SICEL TECHNOLOGIES, INC.
    Date Cleared
    2008-01-23

    (21 days)

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

    SICEL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DVS (Dose Verification System) is intended for use in radiation therapy to verify treatment planning and radiation dose to tissue and organs in or near the irradiated areas of a patient. The DVS system is specifically indicated for breast and prostate cancer to measure photon beam therapy and as an adjunct to treatment planning to permit measurement of the in vivo radiation dose received at the tumor periphery, tumor bed and/or surrounding normal tissues for validation of the prescribed dose.
    Device Description
    The DVS, Dose Verification System consists of four sub-systems: the DVS Implantable Dosimeter for measuring radiation dose in vivo, the DVS Insertion Tool for implanting the dosimeter during percutaneous procedures, the DVS Reader System (Wand and Base Station) for powering the dosimeter and providing a user interface when taking dose measurements, and the DVS Data System (Plan and Review Software and Dosimetery Database) for storing and reporting patient data and for storing dosimeter information. The dosimeters use a MOSFET, Metal Oxide Semiconductor Field Effect Transistor, as a sensing mechanism. The dosimeter is factory calibrated and powered by the Reader Wand utilizing electromagnetic energy. The dosimeter contains a transmitter, to transmit threshold voltage readings to the reader. It is radioopaque and thus registers on computed tomography scans as a point of interest whereby a point dose may be determined. Patients are implanted prior to radiotherapy. Information on the patient's therapy, dose planning, point dose at the dosimeter, dosimeter serial number and calibration files are entered into the Plan and Review software and stored in the Dosimetry Database. At each therapy fraction the dosimeter is read pre- and post-therapy using the Reader Wand and Base Station. This translates into a daily fractional dose. The patient's daily and cumulative dose may be reviewed via the Plan and Review software. Because the Plan and Review software and Dosimetry Database are designed to be stored on a server, multiple users may be logged into the system at any one time. Reports on the patient's daily and cumulative dose history may be printed using the Plan and Review software.
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    K Number
    K071399
    Device Name
    DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100
    Manufacturer
    SICEL TECHNOLOGIES, INC.
    Date Cleared
    2007-06-20

    (30 days)

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

    SICEL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended Use The DVS (Dose Verification System) is intended for use in radiation therapy to verify treatment planning and radiation dose to tissue and organs in or near the irradiated areas of a patient. Indications for Use The DVS system is specifically indicated for breast and prostate cancer to measure photon beam therapy and as an adjunct to treatment planning to permit measurement of the in vivo radiation dose received at the tumor periphery, tumor bed and/or surrounding normal tissues for validation of the prescribed dose.
    Device Description
    The DVS, Dose Verification System consists of four sub-systems: the DVS Implantable Dosimeter for measuring radiation dose in vivo, the DVS Insertion Tool for implanting the dosimeter during percutaneous procedures, the DVS Reader System (Wand and Base Station) for powering the dosimeter and providing a user interface when taking dose measurements, and the DVS Data System (Plan and Review Software and Dosimetery Database) for storing and reporting patient data and for storing dosimeter information. The dosimeters use a MOSFET, Metal Oxide Semiconductor Field Effect Transistor, as a sensing mechanism. The dosimeter is factory calibrated and powered by the Reader Wand utilizing electromagnetic energy. The dosimeter contains a transmitter, to transmit threshold voltage readings to the reader. It is radioopaque and thus registers on computed tomography scans as a point of interest whereby a point dose may be determined. Patients are implanted prior to radiotherapy. Information on the patient's therapy, dose planning, point dose at the dosimeter, dosimeter serial number and calibration files are entered into the Plan and Review software and stored in the Dosimetry Database. At each therapy fraction the dosimeter is read pre- and post-therapy using the Reader Wand and Base Station. This translates into a daily fractional dose. The patient's daily and cumulative dose may be reviewed via the Plan and Review software. Because the Plan and Review software and Dosimetry Database are designed to be stored on a server, multiple users may be logged into the system at any one time. Reports on the patient's daily and cumulative dose history may be printed using the Plan and Review software.
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    K Number
    K061051
    Device Name
    DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTION TOOL, DVS-D-A, DVS DOSIMETER
    Manufacturer
    SICEL TECHNOLOGIES, INC.
    Date Cleared
    2006-06-13

    (57 days)

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

    SICEL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended Use: The DVS (Dose Verification System) is intended for use in radiation therapy to verify treatment planning and radiation dose to tissue and organs in or near the irradiated areas of a patient. Indications for Use: The DVS system is specifically indicated for breast and prostate cancer to measure photon beam therapy and as an adjunct to treatment planning to permit measurement of the in vivo radiation dose received at the tumor periphery, tumor bed and/or surrounding normal tissues for validation of the prescribed dose.
    Device Description
    The DVS, Dose Verification System consists of four sub-systems: the DVS Implantable Dosimeter for measuring radiation dose in vivo, the DVS Insertion Tool for implanting the dosimeter during percutaneous procedures, the DVS Reader System (Wand and Base Station) for powering the dosimeter and providing a user interface when taking dose measurements, and the DVS Data System (Plan and Review Software and Dosimetery Database) for storing and reporting patient data and for storing dosimeter information. The dosimeters use a MOSFET, Metal Oxide Semiconductor Field Effect Transistor, as a sensing mechanism. The dosimeter is factory calibrated and powered by the Reader Wand utilizing electromagnetic energy. The dosimeter contains a transmitter, to transmit threshold voltage readings to the reader. It is radioopaque and thus registers on computed tomography scans as a point of interest whereby a point dose may be determined. Patients are implanted prior to radiotherapy. Information on the patient's therapy, dose planning, point dose at the dosimeter, dosimeter serial number and calibration files are entered into the Plan and Review software and stored in the Dosimetry Database. At each therapy fraction the dosimeter is read pre- and post-therapy using the Reader Wand and Base Station. This translates into a daily fractional dose. The patient's daily and cumulative dose may be reviewed via the Plan and Review software. Because the Plan and Review software and Dosimetry Database are designed to be stored on a server, multiple users may be logged into the system at any one time. Reports on the patient's daily and cumulative dose history may be printed using the Plan and Review software.
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    K Number
    K052118
    Device Name
    DOSE VERIFICATION SYSTEM
    Manufacturer
    SICEL TECHNOLOGIES, INC.
    Date Cleared
    2006-04-03

    (242 days)

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

    SICEL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended Use: The DVS (Dose Verification System) is intended for use in radiation therapy to verify treatment planning and radiation dose to tissue and organs in or near the irradiated areas of a patient. Indications for Use: The DVS system is specifically indicated for breast cancer to measure photon beam therapy and as an adjunct to treatment planning to permit measurement of the in vivo radiation dose received at the tumor periphery, tumor bed and/or surrounding normal tissues for validation of the prescribed dose.
    Device Description
    The DVS, Dose Verification System consists of four sub-systems: the DVS Implantable Dosimeter for measuring radiation dose in vivo, the DVS Insertion Tool for implanting the dosimeter during percutaneous procedures, the DVS Reader System (Wand and Base Station) for powering the dosimeter and providing a user interface when taking dose measurements, and the DVS Data System (Plan and Review Software and Dosimetery Database) for storing and reporting patient data and for storing dosimeter information. The dosimeters use a MOSFET, Metal Oxide Semiconductor Field Effect Transistor as a sensing mechanism. The dosimeter is factory calibrated and powered by the Reader Wand utilizing electromagnetic energy. The dosimeter contains a transmitter, to transmit threshold voltage readings to the reader. It is radioopague and thus registers on computed tomography scans as a point of interest whereby a point dose may be determined. Patients are implanted prior to radiotherapy. Information on the patient's therapy, dose planning, point dose at the dosimeter, dosimeter serial number and calibration files are entered into the Plan and Review software and stored in the Dosimetry Database. At each therapy fraction the dosimeter is read pre- and post-therapy using the Reader Wand and Base Station. This translates into a daily fractional dose. The patient's daily and cumulative dose may be reviewed via the Plan and Review software. Because the Plan and Review software and Dosimetry Database are designed to be stored on a server, up to 25 users may be logged into the system at any one time. Reports on the patient's daily and cumulative dose history may be printed using the Plan and Review software.
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