Electrodiagnostic NCS/EMG/EP System - India CDSCO Medical Device Registration

Product Information

Cadwell Sierra Summit is indicated for acquisition, display, storage, transmission, analysis, and reporting of electrophysiological and environmental data including Electromyography (IONM), Nerve Conduction Studies (IONM), Evoked Potentials (IONM), and Autonomic Reponses (IONM). The Cadwell Sierra Summit is used to detect the physiologic function of the nervous system, and to support the diagnosis of neuromuscular diseases or conditions. The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the peripheral nerve; Electromyography measures the electrical activity of the muscle, and Evoked Potentials measure the electrical activity from the central nervous system. The interface for third-party non-invasive imaging display and control is used to visualize the morphology and location of nerves and muscles, and serves as an aid in confirming the results of the aforementioned modalities. Cadwell Sierra Summit is indicated for use by qualified medical practitioners. This device does not provide any diagnostic conclusion about the patient’s condition to the user