4 devices · 2 companies · 2019 to 2022
ClariPi Inc.: AI-enabled devices on FDA's list
4 devices from ClariPi Inc., 2019 to 2022, 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 (4 of 4 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from ClariPi Inc.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| ClariPulmoK203783 · 510(k) | Radiology | LLZ | database entry | |
| ClariSIGMAMK203785 · 510(k) | Radiology | QIH | database entry | |
| ClariCT.AIK212074 · 510(k) | Radiology | LLZ | database entry | |
| ClariCT.AIK183460 · 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.