Cleared Traditional

K172922 - MMPC-4127F1 (FDA 510(k) Clearance)

Class II Pathology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K172922 is an FDA 510(k) clearance for the MMPC-4127F1. Classified as Digital Pathology Display (product code PZZ), Class II - Special Controls.

Submitted by Barco N.V. (Kortrijk, BE). The FDA issued a Cleared decision on December 21, 2017 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.3700 - the FDA pathology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Barco N.V. devices

Submission Details

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 77d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PZZ Digital Pathology Display
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Pathology devices follow this clearance model.