xT CDx is an AI-enabled medical device from Tempus Labs, Inc., listed by FDA (PMA, P210011) with a decision date of 2023-04-28. Review panel: Pathology.
| FDA submission number | P210011 |
|---|---|
| Pathway | PMA |
| Company | Tempus Labs, Inc. |
| Review panel (specialty) | Pathology |
| FDA decision date | 2023-04-28 |
| Product code | PQP |
| Classification | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System |
| Device class | 3 |
| Review time (calendar days) | 766 |
Official FDA database record · FDA AI-enabled device list
All Pathology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.