2 devices · 2 companies · 2025 to 2026
Artera, Inc.: AI-enabled devices on FDA's list
2 devices from Artera, Inc., 2025 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 (2 of 2 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Artera, Inc.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| ArteraAI BreastK254115 · 510(k) | Pathology | SHW | database entry | |
| ArteraAI ProstateDEN240068 · De Novo | Pathology | SFH | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.