CellaVision DC-1, CellaVision DC-1 PPA is an AI-enabled medical device from CellaVision AB, listed by FDA (510(k), K200595) with a decision date of 2020-10-16. Review panel: Hematology.
| FDA submission number | K200595 |
|---|---|
| Pathway | 510(k) |
| Company | CellaVision AB |
| Review panel (specialty) | Hematology |
| FDA decision date | 2020-10-16 |
| Decision | Substantially Equivalent |
| Product code | JOY |
| Classification | Device, Automated Cell-Locating |
| Device class | 2 |
| Regulation number | 864.5260 |
| Review time (calendar days) | 224 |
| Applicant country | SE |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.