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510(k) Data Aggregation
K Number
K972016Device 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
892.5710Why 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
K970131Device 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
890.5300Why 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
K961725Device 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
888.4580Why 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
K942227Device 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
870.2770Why 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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