K250414 is an FDA 510(k) clearance for the CaloPix. This device is classified as a Digital Pathology Image Viewing And Management Software (Class II - Special Controls, product code QKQ).
Submitted by Tribun Health (Paris, FR). The FDA issued a Cleared decision on May 14, 2025, 90 days after receiving the submission on February 13, 2025.
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 | K250414 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 2025 |
| Decision Date | May 14, 2025 |
| Days to Decision | 90 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. |