9 devices · 3 companies · 1998 to 2025
Hologic, Inc.: AI-enabled devices on FDA's list
9 devices from Hologic, Inc., 1998 to 2025, from 3 companies across 4 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (7 of 9 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Hologic, Inc.
Panels
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Genius AI Detection 2.0K243341 · 510(k) | Radiology | QDQ | database entry | |
| Genius Digital Diagnostics System with the GeniDEN210035 · De Novo | Pathology | QYV | database entry | |
| Genius AI Detection 2.0 with CC-MLO CorrelationK230096 · 510(k) | Radiology | QDQ | database entry | |
| Genius AI Detection 2.0K221449 · 510(k) | Radiology | QDQ | database entry | |
| Genius AI DetectionK201019 · 510(k) | Radiology | QDQ | database entry | |
| QuantraK163623 · 510(k) | Radiology | LLZ | database entry | |
| QUANTRAK142037 · 510(k) | Radiology | LLZ | database entry | |
| QUANTRAK082483 · 510(k) | Radiology | LLZ | database entry | |
| M1000 IMAGECHECKERP970058 · PMA | Radiology | MYN | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.