Personalized Physiology Analytics Engine software is an AI-enabled medical device from VGBio, Inc (DBA PhysIQ), listed by FDA (510(k), K142512) with a decision date of 2015-06-11. Review panel: Cardiovascular.
| FDA submission number | K142512 |
|---|---|
| Pathway | 510(k) |
| Company | VGBio, Inc (DBA PhysIQ) |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2015-06-11 |
| Decision | Substantially Equivalent |
| Product code | PLB |
| Classification | Multivariate Vital Signs Index |
| Device class | 2 |
| Regulation number | 870.2300 |
| Review time (calendar days) | 276 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
All Cardiovascular AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.