Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
The Brain Injury Adjunctive Interpretive EEG Assessment Aid is a prescription device that analyzes a patient's electroencephalograph (EEG) to provide an interpretation of the structural condition of the brain in the setting of trauma, used only as an adjunct to standard clinical practice where other valid diagnostic methods exist. It is an FDA Class 2 device regulated under 21 CFR 882.1450, requiring 510(k) premarket notification, within the Neurology (NE) medical specialty. The product code is PIW. This device is not an implant and is not life-sustaining.
Research product code PIW in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- PIW
- Device Class
- FDA class 2
- Regulation Number
- 882.1450
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243426 | Nurochek-Pro System | Mar 27, 2025 | Substantially Equivalent | Headsafe Mfg Pty, Ltd. |
| K231914 | Nurochek-II System | Dec 27, 2023 | Substantially Equivalent | Headsafe Mfg Pty, Ltd. |
| K190815 | BrainScope TBI | Sep 11, 2019 | Substantially Equivalent | Brainscope Company, Inc. |
| K183241 | BrainScope TBI (Model: Ahead 400) | Feb 19, 2019 | Substantially Equivalent | Brainscope Company, Inc. |
| K181785 | Modified BrainScope One | Dec 19, 2018 | Substantially Equivalent | Brainscope Company, Inc. |
| K181179 | BrainScope One | May 18, 2018 | Substantially Equivalent | Brainscope Company, Inc. |
| K161068 | Ahead 300 | Sep 22, 2016 | Substantially Equivalent | Brainscope Company, Inc. |
| K143643 | Brainscope Ahead 200 | May 15, 2015 | Substantially Equivalent | Brainscope Company, Inc. |
| DEN140025 | BrainScope Ahead 100 | Nov 17, 2014 | Unknown | Brainscope Company, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.