Cleared Traditional

K203364 - MDPC-8127

K203364 is the FDA 510(k) clearance for MDPC-8127 by Barco N.V.. It is a Class 2 Pathology device (product code PSY) cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K203364 · Barco N.V. · Pathology device
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Apr 2021
Decision
150d
Days
Class 2
Risk

K203364 is an FDA 510(k) clearance for the MDPC-8127. Classified as Whole Slide Imaging System (product code PSY), Class II - Special Controls.

Submitted by Barco N.V. (Kortrijk, BE). The FDA issued a Cleared decision on April 15, 2021 after a review of 150 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Barco N.V. devices

Submission Details

510(k) Number K203364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2020
Decision Date April 15, 2021
Days to Decision 150 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
73d slower than avg
Panel avg: 77d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PSY Whole Slide Imaging System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.3700
Definition The Whole Slide Imaging System Is An Automated Digital Slide Creation, Viewing, And Management System Intended As An Aid To The Pathologist To Review And Interpret Digital Images Of Surgical Pathology Slides Prepared From Formalin-fixed, Paraffin-embedded (ffpe) Tissue. The System Generates Digital Images That Would Otherwise Be Appropriate For Manual Visualization By Conventional Brightfield Microscopy. The Whole Slide Imaging System Is Not Intended For Use With Slides Prepared From Frozen Tissue, Cytology, And Non-ffpe Hematopathology Specimens (e.g., Peripheral Blood Smear).
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.

Regulatory Peers - PSY Whole Slide Imaging System

All 18
Devices cleared under the same product code (PSY) and FDA review panel - the closest regulatory comparables to K203364.
NanoZoomer S360MD Slide scanner system
K233027 · Hamamatsu Photonics K.K. · Dec 2023
NanoZoomer S360MD Slide scanner system
K213883 · Hamamatsu Photonics K.K. · Sep 2022
Philips IntelliSite Pathology Solution
K203845 · Philips Medical Systems Nederland B.V. · Sep 2021
Philips IntelliSite Pathology Solution
K192259 · Philips Electronics Nederland B.V. · Sep 2019
Aperio AT2 DX System
K190332 · Leica Biosystems Imaging, Inc. · May 2019
Philips IntelliSite Pathology Solution
K172174 · Philips Medical Systems Nederland B.V. · Oct 2017