K243391 is an FDA 510(k) clearance for the AISight Dx. This device is classified as a Digital Pathology Image Viewing And Management Software (Class II - Special Controls, product code QKQ).
Submitted by PathAI, Inc. (Boston, US). The FDA issued a Cleared decision on June 26, 2025, 238 days after receiving the submission on October 31, 2024.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.3700. Digital Pathology Image Viewing And Management Software Device Is A Software Intended For Viewing And Management Of Digital Images Of Scanned Surgical Pathology Slides Prepared From Formalin-fixed Paraffin Embedded (ffpe) Tissue. It Is An Aid To The Pathologist To Review And Interpret These Digital Images For The Purposes Of Primary Diagnosis..
| 510(k) Number | K243391 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 2024 |
| Decision Date | June 26, 2025 |
| Days to Decision | 238 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | Summary PDF |
| Product Code | QKQ - Digital Pathology Image Viewing And Management Software |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.3700 |
| Definition | Digital Pathology Image Viewing And Management Software Device Is A Software Intended For Viewing And Management Of Digital Images Of Scanned Surgical Pathology Slides Prepared From Formalin-fixed Paraffin Embedded (ffpe) Tissue. It Is An Aid To The Pathologist To Review And Interpret These Digital Images For The Purposes Of Primary Diagnosis. |