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The HealthView ECG Manager is a computer system, used within a clinical network, which is intended to be used by trained professionals. It provides the ability to retrieve, store, edit, send and print ECGs and related digitized clinical documents through the use of on-screen measurement and editing tools. The system receives files (such as ECG, stress, or Holter) from any compatible device, displaying such data to the clinician for analysis and review. The product does not modify the original ECG waveform and does not provide an automated ECG analysis.

HealthView ECG Manager (version 1.0), herein after referred to as ECG Manager, is a Programmable Diagnostic Computer system. It is a "software only" medical device, to be installed on a server and workstation(s) that meet the minimum hardware requirements noted in the documentation. The hardware itself is not considered a medical device and is not part of this 510(k) submission. The device provides a trained user with the ability to find, retrieve, view and integrate ECGs into a single patient record, to assist in the diagnosis and treatment planning of patients. The device does not contact the patient and does not control any life sustaining devices.

CardioPACS is a software device intended to be used by medical professionals, for storage, review, query/ retrieve, analysis and post processing of DICOM medical images as may be generated by echocardiography, radiology and other modalities. The device may be used as a stand-alone product, or in a networked system. CardioPACS is not intended to be used for reading of mammography images.

HealthView CardioPACS (version 6.0), herein after referred to as CardioPACS, is a Picture Archive Communications System. It is a "software only" medical device, to be installed on a server and workstation(s) that meet the minimum hardware requirements noted in the documentation. The hardware itself is not considered a medical device and is not part of this 510(k) submission. The device provides a trained user with the ability to find, retrieve, view, edit and manipulate images on a workstation, to assist in the diagnosis and treatment planning of patients. The device does not contact the patient and does not control any life sustaining devices. CardioPACS is a software-only DICOM-compliant device that can be used on multiple hardware platforms (provided that the minimum hardware requirements are met) that allows viewing, editing, measuring and other digital image processing.