3 devices · 1 company · 2021 to 2023
TheraPanacea: AI-enabled devices on FDA's list
3 devices from TheraPanacea, 2021 to 2023, from 1 company 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 TheraPanacea
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| ART-PlanK232479 · 510(k) | Radiology | MUJ | database entry | |
| ART-PLANK220813 · 510(k) | Radiology | QKB | database entry | |
| ART-PlanK202700 · 510(k) | Radiology | QKB | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.