2 devices · 2 companies · 2021 to 2023
Implicity Inc.: AI-enabled devices on FDA's list
2 devices from Implicity Inc., 2021 to 2023, 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 Implicity Inc.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| SignalHFK230842 · 510(k) | Cardiovascular | QNL | database entry | |
| IM007K210543 · 510(k) | Cardiovascular | DQK | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.