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510(k) Data Aggregation

    K Number
    K034054
    Device Name
    PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100
    Manufacturer
    MED-TEC,INC.
    Date Cleared
    2004-02-20

    (52 days)

    Product Code
    JAI
    Regulation Number
    892.5770
    Why did this record match?
    Applicant Name (Manufacturer) :

    MED-TEC,INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Interface between treatment planning system and the MED-TEC Pro Series Couch; or: Software for MED-TEC Pro Series Couch (6 Degree Axis Couch) .
    Device Description
    Not Found
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    K Number
    K031866
    Device Name
    MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC
    Manufacturer
    MED-TEC,INC.
    Date Cleared
    2003-08-14

    (59 days)

    Product Code
    JAI
    Regulation Number
    892.5770
    Why did this record match?
    Applicant Name (Manufacturer) :

    MED-TEC,INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of this device is to support a patient during radiation therapy; or The intended use of the MED-TEC 6 degree axis couch is to support and aid in positioning a patient during radiologic, radiation therapy, and other medical procedures. The 6 degree axis couch adds Pitch and Roll to the normal X, Y, Z. and Yaw motions. The additional Pitch and Roll make patient alignment simpler without the need to manually move the patent on the table.
    Device Description
    MED-TEC 6 degree axis couch
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    K Number
    K021360
    Device Name
    SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000
    Manufacturer
    MED-TEC,INC.
    Date Cleared
    2003-06-10

    (406 days)

    Product Code
    KXK
    Regulation Number
    892.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    MED-TEC,INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of this device is to act as a quality assurance device to check for the presence of a brachytherapy seed and give indication of dose rate by an audible tone or digital readout on a standard multi meter. The SDF will be used for 'relative' dosimetry. The SDF will be used for 'relative' dosimetry.
    Device Description
    Scintillating Fiber Dosimeter (SFD)
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    K Number
    K023293
    Device Name
    MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02
    Manufacturer
    MED-TEC,INC.
    Date Cleared
    2002-12-23

    (82 days)

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

    MED-TEC,INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of this device is to provide a cutout for displacement of the small bowel from the treatment area. The belly board can be used by it's self or with MED-TEC's HipFix system. The MED-TEC bellyboard is placed on the treatment table and has a cutout that aids in the displacement of the small bowel from the treatment area.
    Device Description
    Not Found
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    K Number
    K013875
    Device Name
    MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE
    Manufacturer
    MED-TEC,INC.
    Date Cleared
    2002-09-27

    (308 days)

    Product Code
    IXI
    Regulation Number
    892.5710
    Why did this record match?
    Applicant Name (Manufacturer) :

    MED-TEC,INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Software translates the ASCII output from a treatment plan to G code for use on a milling machine. Works with various treatment plan outputs and translates the treatment plan into G code that can be used on a milling machine to produce a compensating shield.
    Device Description
    Not Found
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    K Number
    K001052
    Device Name
    MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX
    Manufacturer
    MED-TEC,INC.
    Date Cleared
    2000-08-30

    (149 days)

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

    MED-TEC,INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K981992
    Device Name
    ELECTRON WEDGE MODEL MT-EW-1000
    Manufacturer
    MED-TEC,INC.
    Date Cleared
    1998-12-15

    (190 days)

    Product Code
    IXI
    Regulation Number
    892.5710
    Why did this record match?
    Applicant Name (Manufacturer) :

    MED-TEC,INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of this device is to help provide dose uniformity for electron beam profile.
    Device Description
    MED-TEC, INC. has a Block, Beam-Shaping, Radiation system to be manufactured by MED-TEC, INC.
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    K Number
    K982624
    Device Name
    MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242
    Manufacturer
    MED-TEC,INC.
    Date Cleared
    1998-10-26

    (90 days)

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

    MED-TEC,INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of this device is to provide an additional aid to the fast and accurate repeat positioning of the patient for radiation or other treatment. The device forms to the back of the patient's head and eliminates the usual range of movement of ordinary head cups.
    Device Description
    MoldCare Head & Neck Cushion Model # MT-ACL-14242. A Radiographic head holder System to be manufactured by MED-TEC, INC.
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