3 devices · 2 companies · 2021 to 2026
ABBOTT MEDICAL: AI-enabled devices on FDA's list
3 devices from ABBOTT MEDICAL, 2021 to 2026, from 2 companies across 2 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (3 of 3 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from ABBOTT MEDICAL
Panels
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| OPTIS Mobile Next Imaging SystemK253459 · 510(k) | Radiology | NQQ | database entry | |
| Assert-IQK253516 · 510(k) | Cardiovascular | MXD | database entry | |
| OPTIS Mobile Next Imaging System, OPTIS IntegratK210458 · 510(k) | Radiology | NQQ | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.