DeviceClearance

Product code PIW— Neurology

Ahead 300

Classification name
Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
Device class
Class 2
Regulation
21 CFR 882.1450
Advisory panel
Neurology
Total cleared
9
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code PIW under 21 CFR 882.1450, via openFDA

Market context for product code PIW

FDA has cleared 9 devices under product code PIW between 2014 and 2025, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PIW

Recent clearances under product code PIW

Data sourced from openFDA. This site is unofficial and independent of the FDA.