5 devices · 2 companies · 2001 to 2020
CellaVision AB: AI-enabled devices on FDA's list
5 devices from CellaVision AB, 2001 to 2020, from 2 companies across 1 product code. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (2 of 5 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| CellaVision DC-1, CellaVision DC-1 PPAK200595 · 510(k) | Hematology | JOY | database entry | |
| CELLAVISION DM1200 WITH THE BODY FLUID APPLICTIOK102778 · 510(k) | Hematology | JOY | database entry | |
| CELLAVISION DM96 WITH THE BODY FLUID APPLICATIONK080595 · 510(k) | Hematology | JOY | database entry | |
| CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZERK033840 · 510(k) | Hematology | JOY | database entry | |
| DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZERK003301 · 510(k) | Hematology | JOY | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.