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510(k) Data Aggregation
K Number
K061905Device Name
HORIZON CARDIOLOGY ECG-MCKESSON'S ECG MANAGEMENT SYSTEM, MODEL 1.0
Manufacturer
MEDCON LTD.
Date Cleared
2006-11-08
(126 days)
Product Code
DQK, DOK
Regulation Number
870.1425Why did this record match?
Applicant Name (Manufacturer) :
MEDCON LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Horizon Cardiology ECG™ is a system for importing, storing, displaying and reviewing ECG procedures. Horizon Cardiology ECG is intended for use in the hospital environment by medical professionals.
HC ECG™ is a software application designed for use in various hospital departments, to import, display, store, analyze, distribute and process ECG procedures from resting ECG devices.
The HC ECG™ is intended to provide analysis or reanalysis of resting ECG's and to provide preliminary data for editing and confirmation by an over-reading physician. The HC ECG™ may provide a serial comparison of ECG data to facilitate the review of the patient's current ECG with previous ECG's of the same patient.
Device Description
HC ECG™ is a comprehensive ECG management system for importing ECG waveform data, reviewing and performing measurements, diagnosis and comparison of ECG procedures and storing the data for future review and management.
HC ECG™ functions as a non-real time system. It receives ECG procedure files after the cessation of the ECG procedure, which can originate from any one of a variety of manufacturer's cardiographs. HC ECG™ acquires the ECG waveforms through a network connection or via a diskette, and normalizes them to a common format. If the ECG cart has made an ECG procedure analysis, HC ECG™ presents it and utilizes the Glasgow University Interpretive Algorithm to perform its own measurements, diagnosis and serial comparison without changing the raw waveform data.
The HC ECG™ graphic user interface provides tools that enable the physician to:
- edit measurements. .
- edit procedure diagnoses. .
- review numerous ECG procedures concurrently. .
- confirm ECG procedures. .
- distribute and print ECG procedure reports.
HC ECG™ complies with HL7 standards for export of reports to the Hospital Information System. HC ECG™ supports final ECG report distribution by printing, faxing, e-mailing and automatic export to other systems. The Horizon Cardiology ECG™ database complies with the requirements of HIPAA through robust password security, record access security and file allocation in a secure and managed server.
Horizon Cardiology ECG ™ allows access to ECG records from web-enabled PCs throughout a network and enables authorized clinical users to access the system from remote locations.
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K Number
K050561Device Name
WINDSURFER
Manufacturer
MEDCON LTD.
Date Cleared
2005-05-04
(62 days)
Product Code
DQK
Regulation Number
870.1425Why did this record match?
Applicant Name (Manufacturer) :
MEDCON LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Windsurfer is a system for acquiring, digitizing, storing, displaying and reviewing hemodynamic data (vital signs). The Windsurfer is intended for use in hospital cardiac catheterization laboratories.
Device Description
Windsurfer is a standard hemodynamic monitoring system for monitoring vital signs before, during and after catheterization procedures. Windsurfer is intended to acquire, display, store, analyze and process vital signs and log all cath lab activity. There are tools for entering measurements, calculations and procedure notes. Windsurfer also acquires patient information from other hospital information systems and makes hemodynamic information available to them. Windsurfer is connected to a patient in the cath lab via: - ECG leads . - Invasive Blood Pressure transducers . - . SpO2 finger clip - NIBP cuff . Windsurfer uses an intuitive interface that clearly displays patient data, procedure data, waveforms and numeric values. The performing physician views the monitor in the cath lab and conveys instructions and procedure notes to the certified technician, who operates the application using a touch screen, keyboard and mouse, for maximum convenience.
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K Number
K974679Device Name
THE TCS-MEDCON'S TELECARDIOLOGY SYSTEM
Manufacturer
MEDCON LTD.
Date Cleared
1998-03-23
(98 days)
Product Code
IZI
Regulation Number
892.1600Why did this record match?
Applicant Name (Manufacturer) :
MEDCON LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TCS is a software device intended to acquire, print, archive and communicate catheterization laboratory image studies, and to view these images on a PC in real-time mode. In addition, the TCS is intended to provide image enhancement and filtering tools for the viewing of selected images, to import and generate DICOM CDs, to prepare reports in Microsoft® Word format and to export DICOM images into commercial file formats.
Device Description
The TCS provides a complete software tool for the convenient and efficient recording, storage, review, and communication of heart catheterization and other angiographic studies In the catheterization lab environment. The TCS also creates DICOM 3.0 CDs from the cath lab procedures. The TCS operates on a WindowsNT® PC. The TCS automatically acquires the x-ray video signal and places each video inside the patient's file. The patient file may also contain single images from a video, and reports (which automatically include the full patient details and selected images from the procedure) in Microsoft® Word format. During the review of videos and single images, image enhancement tools, such as zooming, magnification, full screen view, playback loop and brightness, contrast and gamma controls may be applied. As well as creating DICOM CDs, the TCS can also import data from DICOM CDs into its database, where they are written as patient files. Data may also be introduced to the TCS via telecardiology over an ISDN line, enabling professional consultation and referral of patients from level to level of the cardiac health care system. The patient files sent and received via telecardiology may also have vocal and graphic annotations attached to them. All new patient files, whether acquired from x-ray, imported from a DICOM CD, or received via telecardiology, are logged so that their source and ownership may easily be determined.
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K Number
K971181Device Name
THE MIDVIEW-MEDCON'S DICOM VIEWER
Manufacturer
MEDCON LTD.
Date Cleared
1997-07-29
(120 days)
Product Code
IZI
Regulation Number
892.1600Why did this record match?
Applicant Name (Manufacturer) :
MEDCON LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MOVIEW is a software device vicently , print and save cardia. In the same income studio refrieve refrieve, display, profit and into in a mage studio cathelerization faboration and to view these real-Time mode PC images on Cu
Device Description
The MDVIEW is a software device intended to retrieve, display, print and save cardiac catheterization laboratory image studies from CD-R media, and to view these images on a PC computer in real time mode. Digital imaging from the cardiac catheterization laboratory is recorded on the CD-R in conformance with the DICOM standard. These loss free images provide physicians with a valuable tool for diagnostic review and analysis.
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