K233126 is an FDA 510(k) clearance for the aetherSlide. This device is classified as a Digital Pathology Image Viewing And Management Software (Class II - Special Controls, product code QKQ).
Submitted by Aetherai Co., Ltd. (Taipei City, TW). The FDA issued a Cleared decision on May 30, 2024, 246 days after receiving the submission on September 27, 2023.
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 | K233126 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2023 |
| Decision Date | May 30, 2024 |
| Days to Decision | 246 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. |