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The SPARK Scan is intended to acquire, display, and store the electrical activity of a patient's brain obtained by placing two or more electrodes on the head to aid in diagnosis.

The SPARK Scan is intended for the acquisition, display, and storage of electroencephalogram (EEG) data. The SPARK Scan is intended to be used by EEG technicians, or appropriately trained Nurses and Medical Assistants practicing in any medical setting where EEG data collection may be required. The SPARK Scan is an SaMD product that consists of the Edge Software and Data Storage and Communication Platform. The Edge software runs locally on the user's device and consists of a User interface and the EEG hardware interface, including the electroconductive gel (K1117). The User Interface is a desktop application that (a) manages interaction with the EEG hardware interface, (b) facilitates set up and recording of EEG data, and (c) provides limited access to review of patient records according to the user's permissions. The Data Storage and Communication Platform (Cloud Software): The Cloud software runs on a server managed by SPARK Neuro and contains no user interface. The Cloud Software is responsible only for managing (a) authorization and authentication of users and (b) storage, validation, and access to all data collected on the system. The SPARK Scan is compatible with three 3rd-party accessory devices: an FDA-cleared EEG hardware system, a standard off-the-shelf-laptop, and FDA-cleared EEG Recording Viewing Platforms.