PIW — Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid Class II
FDA product code PIW covers "Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid", a Class II medical device regulated under 21 CFR 882.1450. Submissions are reviewed by the Neurology panel. At least 9 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PIW
- Device Class
- Class II
- Regulation Number
- 882.1450
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243426 | headsafe mfg pty | Nurochek-Pro System | March 27, 2025 |
| K231914 | headsafe mfg pty | Nurochek-II System | December 27, 2023 |
| K190815 | brainscope company | BrainScope TBI | September 11, 2019 |
| K183241 | brainscope company | BrainScope TBI (Model: Ahead 400) | February 19, 2019 |
| K181785 | brainscope company | Modified BrainScope One | December 19, 2018 |
| K181179 | brainscope company | BrainScope One | May 18, 2018 |
| K161068 | brainscope company | Ahead 300 | September 22, 2016 |
| K143643 | brainscope company | Brainscope Ahead 200 | May 15, 2015 |
| DEN140025 | brainscope company | BrainScope Ahead 100 | November 17, 2014 |