6 devices · 3 companies · 2017 to 2025
Arterys, Inc.: AI-enabled devices on FDA's list
6 devices from Arterys, Inc., 2017 to 2025, from 3 companies across 2 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (6 of 6 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Arterys, Inc.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Tempus PixelK252539 · 510(k) | Radiology | QIH | database entry | |
| Arterys MICAK203744 · 510(k) | Radiology | QIH | database entry | |
| Arterys MICAK192437 · 510(k) | Radiology | QIH | database entry | |
| Arterys MICAK182034 · 510(k) | Radiology | LLZ | database entry | |
| Arterys Oncology DLK173542 · 510(k) | Radiology | LLZ | database entry | |
| Arterys Cardio DLK163253 · 510(k) | Radiology | LLZ | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.