Search Results

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.

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.

The provided documentation is a 510(k) summary for the Horizon Cardiology ECG™ system. It describes the device, its intended use, and indicates that it has been found substantially equivalent to predicate devices. However, the document does NOT contain information about specific acceptance criteria or a study that proves the device meets those criteria. Such detailed performance data and study results are typically found in the full 510(k) submission, which is not publicly available in this summary format.

Therefore, I cannot provide the requested information based solely on the provided text. The document focuses on regulatory approval based on substantial equivalence, not on a detailed clinical performance study with acceptance criteria.

To answer your request, if the information were available, here's how it would be structured and what details would be needed:

Acceptance Criteria and Device Performance Study (Information Not Found in Provided Text)

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device