Cleared Traditional

MMPC-4127F1

K172922 · Barco N.V. · Pathology
Dec 2017
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K172922 is an FDA 510(k) clearance for the MMPC-4127F1, 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 review panel. Regulated under 21 CFR 864.3700.

Submission Details

510(k) Number K172922 FDA.gov
FDA Decision Cleared 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

Device Classification

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.