6 devices · 2 companies · 2021 to 2026
Lunit, Inc.: AI-enabled devices on FDA's list
6 devices from Lunit, Inc., 2021 to 2026, 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 (5 of 6 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Lunit, Inc.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Lunit INSIGHT MMGK260320 · 510(k) | Radiology | QDQ | database entry | |
| Lunit INSIGHT DBTK253796 · 510(k) | Radiology | QDQ | database entry | |
| Lunit INSIGHT DBT v1.1K242652 · 510(k) | Radiology | QDQ | database entry | |
| Lunit INSIGHT DBTK231470 · 510(k) | Radiology | QDQ | database entry | |
| Lunit INSIGHT MMGK211678 · 510(k) | Radiology | QDQ | database entry | |
| Lunit INSIGHT CXR TriageK211733 · 510(k) | Radiology | QFM | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.