Triton System is an AI-enabled medical device from GAUSS SURGICAL INC., listed by FDA (510(k), K160338) with a decision date of 2016-08-05. Review panel: General Hospital.
| FDA submission number | K160338 |
|---|---|
| Pathway | 510(k) |
| Company | GAUSS SURGICAL INC. |
| Review panel (specialty) | General Hospital |
| FDA decision date | 2016-08-05 |
| Decision | Substantially Equivalent |
| Product code | PBZ |
| Classification | Image Processing Device For Estimation Of External Blood Loss |
| Device class | 2 |
| Regulation number | 880.2750 |
| Review time (calendar days) | 179 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
All General Hospital AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.