K210811 is an FDA 510(k) clearance for the Dynamyx Digital Pathology Software. This device is classified as a Digital Pathology Image Viewing And Management Software (Class II - Special Controls, product code QKQ).
Submitted by Inspirata, Inc. (Tampa, US). The FDA issued a Cleared decision on March 1, 2022, 349 days after receiving the submission on March 17, 2021.
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 | K210811 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 17, 2021 |
| Decision Date | March 01, 2022 |
| Days to Decision | 349 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. |