K242545 is an FDA 510(k) clearance for the RadiForce MX317W-PA. This device is classified as a Digital Pathology Display (Class II - Special Controls, product code PZZ).
Submitted by Eizo Corporation (Hakusan, JP). The FDA issued a Cleared decision on May 23, 2025, 269 days after receiving the submission on August 27, 2024.
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 | K242545 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 27, 2024 |
| Decision Date | May 23, 2025 |
| Days to Decision | 269 days |
| Submission Type | Abbreviated |
| 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. |