BrainScope TBI is an AI-enabled medical device from BrainScope Company, Inc. that the U.S. FDA cleared through 510(k) K190815 on September 11, 2019. Its lead review panel is Neurology and its primary product code is PIW (Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid).
See also FDA-cleared AI neurology devices in 2019, all FDA AI clearances in 2019, top neurology AI devices.
Key facts
| Submission number | K190815 |
|---|---|
| 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. BrainScope TBI went through this pathway (K190815).
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 #4 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.
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