Neurology · 510(k) · 2015
Brainscope Ahead 200
BRAINSCOPE COMPANY, INC.. Cleared by FDA on 15 May 2015 under submission K143643, product code PIW (brain injury adjunctive interpretive electroencephalograph assessment aid). What FDA's record says, in FDA's words.
Device record · K143643
- Device. Brainscope Ahead 200DEVICE
- Company. BRAINSCOPE COMPANY, INC.COMPANY
- Decision. 15 May 2015, 510(k), substantially equivalent (traditional review); received 22 December 2014DECISION
- Panel. NeurologyPANEL
- Product code. PIW, Brain Injury Adjunctive Interpretive Electroencephalograph Assessment AidCODE
- Regulation. 21 CFR 882.1450, Class IIREG
- Source. FDA database entry · decision document (16 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
• The Ahead 200, consisting of two models, i.e., the Ahead M-200 and the Ahead CV-200, is indicated for use as an adjunct to standard clinical practice to aid in the evaluation of patients who are being considered for a head CT, but should not be used as a substitute for a CT scan. This device is to be used for this purpose in patients who sustained a closed head injury within 24 hours, clinically present as a mild traumatic brain injury with a Glasgow Coma Scale score (GCS) of 13-15, and are between the ages of 18-80 years. • A negative BrainScope Classification may correspond to brain electrical activity consistent with no structural brain injury visible on head CT in patients presenting as a mild traumatic brain injury, within 24 hours of injury. • A positive BrainScope Classification corresponds to brain electrical activity that may be present in both patients with or without a structural brain injury visible on head CT. A positive BrainScope Classification does not establish the presence of a structural brain injury visible on head CT. • The Ahead 200 device is intended to record, measure, analyze, and display brain electrical activity utilizing the calculation of standard quantitative EEG (qEEG) parameters from frontal locations on a patient’s forehead. The Ahead 200 calculates and displays raw measures for the following standard qEEG measures: Absolute and Relative Power, Asymmetry, Coherence and Fractal Dimension. These raw measures are intended to be used […]
The product code's definition, from FDA's classification record. A prescription device that uses a patient¿s electroencephalograph (EEG) to provide an interpretation of the structural condition of the patient¿s brain in the setting of trauma. The Brain Injury Adjunctive Interpretive EEG Assessment Aid is for use as an adjunct to standard clinical practice only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedCT
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsmeasurement or quantification
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code PIW. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code PIW, in Neurology, from BRAINSCOPE COMPANY, INC., or cleared in 2015. The whole record is at FDA AI-enabled medical devices.
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