SPECIFICATIONS
The world's first FDA-cleared portable brain scanner.Please see Indications for Use page for FDA specifics. Technical details and regulatory information for Nurochek™.
Device
Software
Regulatory
Clinical Use
INDICATIONS FOR USE
510(k): K243426The Nurochek™-Pro System is intended for prescription use in healthcare facilities for patients aged between 12 and 44 years old, for the aid in diagnosis of mild traumatic brain injury (mTBI) in conjunction with a standard neurological assessment.
The Nurochek™-Pro System is indicated for the generation of visual evoked potentials (VEP) and to acquire, transmit, display, and store electroencephalograms (EEG) during the generation of VEPs. Additionally, the system is indicated to analyze captured EEG signals to provide an aid in the diagnosis of mild traumatic brain injury (mTBI) in subjects aged between 12 and 44 years old who have sustained a potential head injury in the past 120 hours (5 days).
Nurochek™-Pro is intended to be used as part of a comprehensive clinical evaluation and is not a standalone diagnostic device. Results should be interpreted by qualified healthcare providers in conjunction with clinical examination, patient history, and other diagnostic information.
BEHIND THE SIMPLICITY LIES DEEP SCIENCE
Analyzed per scan using proprietary algorithms
Of AI and machine-learning development and validation
International patents protecting our technology
From start to objective results, anywhere
Nurochek™ uses EEG and Visual Evoked Potential (VEP) technology to measure actual brain function — data that cannot be manipulated, minimized, or misreported. No baseline required.
QUESTIONS ABOUT SPECIFICATIONS?
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