K172922 is an FDA 510(k) clearance for the MMPC-4127F1. This device is classified as a Digital Pathology Display (Class II - Special Controls, product code PZZ).
Submitted by Barco N.V. (Kortrijk, BE). The FDA issued a Cleared decision on December 21, 2017, 87 days after receiving the submission on September 25, 2017.
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 | K172922 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 2017 |
| Decision Date | December 21, 2017 |
| Days to Decision | 87 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. |