Ahead 300 is an AI-enabled medical device from BRAINSCOPE COMPANY INC that the U.S. FDA cleared through 510(k) K161068 on September 22, 2016. Its lead review panel is Neurology and its primary product code is PIW (Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid).
See also all FDA AI clearances in 2016, top neurology AI devices.
Key facts
| Submission number | K161068 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | BRAINSCOPE COMPANY INC |
| Lead review panel | Neurology |
| Primary product code | PIW — Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid |
| Applicant (openFDA) | Brainscope Company, Inc. |
| Applicant location | Bethesda, MD, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 882.1450 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Ahead 300 went through this pathway (K161068).
openFDA lists it as a Class 2 device under 21 CFR 882.1450. Class II devices are moderate risk and are subject to general and special controls.
Product code PIW covers 4 devices on the FDA AI list. By decision date, this device is #3 of 4 under that code. BRAINSCOPE COMPANY INC has 4 AI-enabled devices on the list, and the Neurology panel accounts for 73 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.
Similar devices (product code PIW)
- BrainScope TBIBrainScope Company, Inc. · Neurology
- Brainscope Ahead 200BRAINSCOPE COMPANY, INC. · Neurology
- BrainScope Ahead 100BRAINSCOPE COMPANY, INC · Neurology