Electrodiagnostic NCS/EMG/EP System
- UID
- IMP/MD/2023/000568_73b6ad70fcdd8a9e37352bbbb74ce49c_64fb06031208ca689c58bedd1c945fc7
- Device class
- Class C
- Brand name
- IONM
- License holder
- Morulaa Health Tech Pvt Ltd
- Approving authority
- CDSCO
- 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
Electrodiagnostic NCS/EMG/EP System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000568_73b6ad70fcdd8a9e37352bbbb74ce49c_64fb06031208ca689c58bedd1c945fc7. This device is marketed under the brand name IONM. The license holder is Morulaa Health Tech Pvt Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.
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