K233119 is an FDA 510(k) clearance for the 8MP Color LCD Displays C811W, C811WT, PA27 and PA27T. This device is classified as a Digital Pathology Display (Class II - Special Controls, product code PZZ).
Submitted by Shenzhen Beacon Display Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 28, 2024, 458 days after receiving the submission on September 27, 2023.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.3700. The Digital Pathology Display Device Is Intended For In Vitro Diagnostic Use To Display Digital Images Of Histopathology Slides Acquired From Fda-cleared Whole-slide Imaging Scanners That Are Used For Review And Interpretation By Trained Pathologists..
| 510(k) Number | K233119 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2023 |
| Decision Date | December 28, 2024 |
| Days to Decision | 458 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | Summary PDF |
| Product Code | PZZ - Digital Pathology Display |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.3700 |
| Definition | The Digital Pathology Display Device Is Intended For In Vitro Diagnostic Use To Display Digital Images Of Histopathology Slides Acquired From Fda-cleared Whole-slide Imaging Scanners That Are Used For Review And Interpretation By Trained Pathologists. |