| Decision | Number | Device | Company | Panel |
|---|---|---|---|---|
| 2026-05-04 | K254115 | ArteraAI Breast | Artera, Inc. | Pathology |
| 2025-12-09 | K243449 | INFINITT DPS | Infinitt Healthcare Co., Ltd. | Pathology |
| 2025-08-29 | K250003 | GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) | Geneseeq Technology Inc. | Pathology |
| 2025-07-31 | DEN240068 | ArteraAI Prostate | Artera Inc. | Pathology |
| 2025-01-24 | K241232 | Galen™ Second Read™ | Ibex Medical Analytics Ltd. | Pathology |
| 2024-01-31 | DEN210035 | “Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm” | Hologic Inc. | Pathology |
| 2023-04-28 | P210011 | xT CDx | Tempus Labs, Inc. | Pathology |
| 2021-09-21 | DEN200080 | Paige Prostate | Paige.AI | Pathology |
| 1995-11-08 | P940029 | PAPNET Testing System | Neuromedical Systems, Inc. | Pathology |
| 1995-09-29 | P950009 | AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM | BD DIAGNOSTICS | Pathology |