INFINITT DPS is an AI-enabled medical device from Infinitt Healthcare Co., Ltd., listed by FDA (510(k), K243449) with a decision date of 2025-12-09. Review panel: Pathology.
| FDA submission number | K243449 |
|---|---|
| Pathway | 510(k) |
| Company | Infinitt Healthcare Co., Ltd. |
| Review panel (specialty) | Pathology |
| FDA decision date | 2025-12-09 |
| Decision | Substantially Equivalent |
| Product code | QKQ |
| Classification | Digital Pathology Image Viewing And Management Software |
| Device class | 2 |
| Regulation number | 864.3700 |
| Review time (calendar days) | 397 |
| Applicant country | KR |
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.