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510(k) Data Aggregation
K Number
K960665Device Name
ECHO-COM FOR MS-WINDOWS VERSION 2.0
Manufacturer
Date Cleared
1996-05-07
(77 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
CONE INSTRUMENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ECHO-COM for MS-Windows Version 2.0 cardiac software program is recommended for quantitative analysis of M-mode, B-mode, and Doppler ultrasound data. The system may be employed adjunctively in the performance of stress echocardiography in patients with suspected coronary artery disease either on-line by direct connection to the video signal output port of a suitable diagnostic ultrasound system or off-line by retrieving and processing previously stored data. The system permits the use of either standard or customized examination protocols, data analysis formulae, and report formats.
Device Description
The ECHO-COM device is a proprietary software program for cardiac data analysis designed for installation in an IBM-compatible personal computer (PC) and use with an MS-DOS Windows operating platform. Certain dedicated hardware items are provided with the software. The PC itself and the general-purpose peripheral hardware necessary to complete the system are supplied by or obtained from local vendors. The dedicated hardware supplied with the ECHO-COM system consists of a real-time frame grabber, ECG trigger kit, control panel, hardlock, and video cable. The digitizer card interface for the frame grabber has sufficient memory for the processing and storage of color images. This frame grabber captures all available information from the ultrasound system with which it is used during on-line operation including ECG trigger pulses and scale markers for distance measurements. The ECG trigger pulses permit time-gated cine loop recording, optimizing the system for the performance of stress-echo examinations. ECHO-COM software is designed to offer exceptional flexibility during either on-line or off-line operation. Images and cine loops may be archived in a variety of commonly used formats, including Macintosh, permitting integration into a wide range of networking systems such as InterNet and CompServe for convenient transfer of data to remote locations. A Review Module is provided that enables users to perform measurement, calculation, and documentation of stored images and loops at the workstation. An Examination Scheme Editor permits the user to supplement the pre-programmed protocols with customized examination approaches to conform with local requirements and preferences. Data from 2-D, M-mode, and Doppler examinations can be combined as desired. Levels and scanning positions for stress-echo examinations can be freely selected. The Report and Formula Editor enables the user to add custom-designed report formats and supplementary calculation formulae to the standard menu. A comprehensive range of cardiac ultrasound examination programs is provided including stress-echo test computations, semi-quantitative wall motion scoring, wall thickness evaluation, left ventricular volume studies, left ventricular function, color coding, M-mode functions, and Doppler functions. The disc summation method for quantitation of left ventricular volumes by two-dimensional echocardiography, as recommended by the American Society of Echocardiography, is employed. The tolerance levels utilized in the ECHO-COM program are based directly on the range of normal values adopted by the American Society of Echocardiography. All other equations and formulae included in the ECHO-COM program are based on accepted mathematical principles or derived from the published literature.
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