4 devices · 3 companies · 2019 to 2025
Cleerly, Inc.: AI-enabled devices on FDA's list
4 devices from Cleerly, Inc., 2019 to 2025, from 3 companies across 3 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 Cleerly, Inc.
Panels
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Cleerly LABSK242338 · 510(k) | Radiology | QIH | database entry | |
| Cleerly ISCHEMIAK231335 · 510(k) | Cardiovascular | QXZ | database entry | |
| Cleerly Labs v2.0K202280 · 510(k) | Radiology | LLZ | database entry | |
| Cleerly LabsK190868 · 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.