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510(k) Data Aggregation

    K Number
    K011220
    Device Name
    LEVEEN REFLECT MONOPOLAR/BIPOLAR NEEDLE ELECTRODE
    Manufacturer
    RADIOTHERAPEUTICS CORP.
    Date Cleared
    2002-07-01

    (437 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIOTHERAPEUTICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K012315
    Device Name
    LEVEEN ELECTRODE
    Manufacturer
    RADIOTHERAPEUTICS CORP.
    Date Cleared
    2001-10-11

    (80 days)

    Product Code
    GEI, JOS
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIOTHERAPEUTICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LeVeen™ Electrode is intended to be used in conjunction with a RadioTherapeutics Corporation radiofrequency (RF) generator for the thermal coagulation necrosis of soft tissue, including partial or complete ablation of nonresectable liver lesions.
    Device Description
    The device consists of a preshaped, multi-armed electrode array which is contained within a delivery cannula. The array is attached to a handle mechanism that deploys the array into the targeted tissue. In addition, each device is supplied with an insulated introducer sheath/stylet assembly to allow the physician to locate the target tissue prior to placing and deploying the electrode. The device is connected to a RadioTherapeutics RF generator so that RF energy passes from the array to a patient ground pad and heats the tissue surrounding the array.
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    K Number
    K000241
    Device Name
    RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR
    Manufacturer
    RADIOTHERAPEUTICS CORP.
    Date Cleared
    2000-04-14

    (78 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIOTHERAPEUTICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K982556
    Device Name
    LEVEEN NEEDLE ELECTRODE
    Manufacturer
    RADIOTHERAPEUTICS CORP.
    Date Cleared
    2000-04-06

    (624 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIOTHERAPEUTICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LeVeen Needle Electrode is intended to be used in conjunction with a RadioTherapeutics Corporation radiofrequency (RF) generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
    Device Description
    Not Found
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    K Number
    K000032
    Device Name
    LEVEEN NEEDLE ELECTRODE
    Manufacturer
    RADIOTHERAPEUTICS CORP.
    Date Cleared
    2000-03-30

    (85 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIOTHERAPEUTICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K982854
    Device Name
    MR COMPATIBLE LEVEEN NEEDLE ELECTRODE
    Manufacturer
    RADIOTHERAPEUTICS CORP.
    Date Cleared
    1998-11-10

    (89 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIOTHERAPEUTICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MR Compatible LeVeen Needle Electrode is intended to be used in conjunction with separately approved RF Generators such as the RadioTherapeutics RF-2000, for the thermal coagulation necrosis of soft tissues.
    Device Description
    MR Compatible LeVeen Needle Electrode
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    K Number
    K981672
    Device Name
    RADIOTHERAPEUTICS RF-2000 RADIOFREQUENCY GENERATOR
    Manufacturer
    RADIOTHERAPEUTICS CORP.
    Date Cleared
    1998-07-17

    (66 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIOTHERAPEUTICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RadioTherapeutics Corp. RF Generator is a medium power electrosurgical generator intended for use with separately approved electrodes for the thermal coagulation of soft tissues.
    Device Description
    RadioTherapeutics RF-2000 Radiofrequency Generator
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    K Number
    K972441
    Device Name
    RADIOTHERAPEUTICS RF GENERATOR. MODEL #RF-2000
    Manufacturer
    RADIOTHERAPEUTICS CORP.
    Date Cleared
    1997-09-04

    (66 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIOTHERAPEUTICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RadioTherapeutics Corp. RF Generator is a medium power electrosurgical generator intended for use with separately approved electrodes for the thermal coagulation of soft tissues.
    Device Description
    Not Found
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    K Number
    K962313
    Device Name
    MODIFIED LEVEEN NEEDLE ELECTRODE
    Manufacturer
    RADIOTHERAPEUTICS CORP.
    Date Cleared
    1996-09-11

    (86 days)

    Product Code
    JOS
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIOTHERAPEUTICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K962386
    Device Name
    SENSOR SHEATH TS1
    Manufacturer
    RADIOTHERAPEUTICS CORP.
    Date Cleared
    1996-08-20

    (61 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIOTHERAPEUTICS CORP.

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

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