FDA Product Code PIW: Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
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.
Leading manufacturers include Headsafe Mfg Pty, Ltd..
FDA 510(k) Cleared Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid Devices (Product Code PIW)
About Product Code PIW - Regulatory Context
510(k) Submission Activity
9 total 510(k) submissions under product code PIW since 2014, with 8 receiving FDA clearance (average review time: 129 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
FDA review times for PIW submissions have been consistent, averaging 143 days recently vs 127 days historically.
PIW devices are reviewed by the Neurology panel. Browse all Neurology devices →