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510(k) Data Aggregation

    K Number
    K972016
    Device Name
    AUTIMO 2.5-D AND AUTIMO 3-D
    Manufacturer
    C.L. MCINTOSH & ASSOC., INC.
    Date Cleared
    1997-12-04

    (188 days)

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

    **C.L. MCINTOSH **& ASSOC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 2.5-D and 3-D AUTIMO Systems are intended for the fabrication and positioning in radiotherapy of irregular shielding blocks, dose modifiers, and compensators.
    Device Description
    The AUTIMO 2.5-D and 3-D models are computer-controlled cutting tool systems for producing customized shielding blocks for use in radiotherapy. The computer accepts files from existing treatmentplanning system operating on a LAN. The GE-Target, Siemens Helax, and Theratronics Theraplan systems are examples of such treatmentplanning software. The computer interprets the files from the planning system and communicates with the AUTIMO device through a serial port.
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    K Number
    K970131
    Device Name
    ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE
    Manufacturer
    C.L. MCINTOSH & ASSOC., INC.
    Date Cleared
    1997-06-16

    (153 days)

    Product Code
    IMI
    Regulation Number
    890.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    **C.L. MCINTOSH **& ASSOC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Orthosonics Duo-Son Ultrasound Diathermy Device is intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures.
    Device Description
    The Orthosonics Duo-Son Ultrasound Diathermy Device consists of a two-channel power module which generates the ultrasonic energy and provides overall control of the device, and a handpiece with cable. The applicator design allows the simultaneous delivery of ultrasonic energy to tissue at two frequencies, 1 MHz and 45 kHz.
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    K Number
    K961725
    Device Name
    OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION
    Manufacturer
    C.L. MCINTOSH & ASSOC., INC.
    Date Cleared
    1996-08-01

    (90 days)

    Product Code
    JDX
    Regulation Number
    888.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    **C.L. MCINTOSH **& ASSOC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OSCAR Orthosonics System for Cemented Arthroplasty Revision is intended to assist in the removal of polymethylmethacrylate (PMMA) bone cement during arthroplasty revision.
    Device Description
    The OSCAR Orthosonics Ultrasonic Cement Removal System consists of a power module which generates the ultrasonic energy and provides overall control of the device, a handpiece, a set of cement removal probes, and an ultrasonic cleaning system for part of the reprocessing procedures for reuse of the probes. Three independent power modules are included in each device and these are mounted in a cart for ease of use.
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    K Number
    K942227
    Device Name
    NICAS 2001 NONINVASIVE CARDIO-RESPIRATORY SYSTEM
    Manufacturer
    C.L. MCINTOSH & ASSOC., INC.
    Date Cleared
    1996-06-28

    (784 days)

    Product Code
    DSB
    Regulation Number
    870.2770
    Why did this record match?
    Applicant Name (Manufacturer) :

    **C.L. MCINTOSH **& ASSOC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NICaS 2001 is intended for use in monitoring hemodynamic parameters (including stroke volume, stroke index, heart rate, cardiac index, cardiac output, and total peripheral resistance) and ventilatory parameters (respiratory rate) in males and females needing cardiac output assessment, including patients with cardiovascular disorders, patients undergoing cardiac catheterization, cardiac surgery patients and patients in intensive and cardiac care units and rehabilitation.
    Device Description
    The NICaS 2001 is a noninvasive cardio-respiratory monitor which unlizes bioimpedance measurements from the blood circulatory system to calculate hemodynamic parameters (including stroke volume, stroke index, heart rate, cardiac index and total peripheral resistance) and ventilatory parameters (including respiratory rate). The NCaS 2001 uses 4 electrodes that pick up the signals which are amplified inside the patient module. After signal amplification and filtration, the analysis is done by a powerful microprocessor. The microprocessor-driven software includes unique algorithms that reject artifacts and perform all required calculations for stroke volume (SV) and other derived parameters. The results are displayed on a PC screen. The software allows data storage, recall/review and printout. The electrodes are nondisposable (standard electrode by Nicolet) "strap" style attached to cable leads. These electrodes consist of two 55 cm electrode strips for the leg and two 25 cm electrode strips for the arm. The electrodes are attached to the two identified input connectors of the patient module. The patient module also connects with the computer.
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