10 devices · 10 companies · 1995 to 2026
AI-enabled pathology devices on FDA's list
10 devices in the Pathology panel, 1995 to 2026, from 10 companies across 9 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (8 of 10 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes in the Pathology panel
- QPN · Software Algorithm Device To Assist Users In Digital Pathology2
- SHW · Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis1
- QKQ · Digital Pathology Image Viewing And Management Software1
- PZM · Next Generation Sequencing Based Tumor Profiling Test1
- SFH · Pathology Software Algorithm Device Analyzing Digital Images For Prostate Cancer Prognosis1
- QYV · Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm1
- PQP · Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System1
- MNM · Reader, Cervical Cytology Slide, Automated1
- NMN · Instrument, Clip, Forming/Cutting, Reprocessed1
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Product code | FDA |
|---|---|---|---|---|
| ArteraAI BreastK254115 · 510(k) | Artera, Inc. | SHW | database entry | |
| INFINITT DPSK243449 · 510(k) | Infinitt Healthcare Co., Ltd. | QKQ | database entry | |
| GENESEEQPRIME NGS Tumor Profiling AssayK250003 · 510(k) | Geneseeq Technology Inc. | PZM | database entry | |
| ArteraAI ProstateDEN240068 · De Novo | Artera Inc. | SFH | database entry | |
| Galen Second ReadK241232 · 510(k) | Ibex Medical Analytics Ltd. | QPN | database entry | |
| Genius Digital Diagnostics System with the GeniDEN210035 · De Novo | Hologic Inc. | QYV | database entry | |
| xT CDxP210011 · PMA | Tempus Labs, Inc. | PQP | database entry | |
| Paige ProstateDEN200080 · De Novo | Paige.AI | QPN | database entry | |
| PAPNET Testing SystemP940029 · PMA | Neuromedical Systems, Inc. | MNM | database entry | |
| AUTOPAPP950009 · PMA | BD DIAGNOSTICS | NMN | database entry |
Every panel in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.