BrainScope TBI
FDA 510(k) clearance K190815 · decided 2019-09-11
Clearance details
- K-number
- K190815
- Device name
- BrainScope TBI
- Applicant
- Brainscope Company, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-03-29
- Decision date
- 2019-09-11
- Days to decision
- 166 days
- Clearance type
- Traditional
- Product code
- PIW
- Device class
- 2
- Regulation number
- 882.1450
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Bethesda, MD, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Nurochek-Pro System (K243426) | Headsafe Mfg Pty, Ltd. | 2025-03-27 |
| Nurochek-II System (K231914) | Headsafe Mfg Pty, Ltd. | 2023-12-27 |
| BrainScope TBI (Model: Ahead 400) (K183241) | Brainscope Company, Inc. | 2019-02-19 |
| Modified BrainScope One (K181785) | Brainscope Company, Inc. | 2018-12-19 |
| BrainScope One (K181179) | Brainscope Company, Inc. | 2018-05-18 |
| Ahead 300 (K161068) | Brainscope Company, Inc. | 2016-09-22 |
| Brainscope Ahead 200 (K143643) | Brainscope Company, Inc. | 2015-05-15 |
| BrainScope Ahead 100 (DEN140025) | Brainscope Company, Inc. | 2014-11-17 |
Recalls involving this device
No recalls on record reference this clearance.