Cleared Traditional

MDPC-8127

K203364 · Barco N.V. · Pathology

Apr 2021

Decision

150d

Days

Class 2

Risk

About This 510(k) Submission

K203364 is an FDA 510(k) clearance for the MDPC-8127, a Whole Slide Imaging System (Class II — Special Controls, product code PSY), submitted by Barco N.V. (Kortrijk, BE). The FDA issued a Cleared decision on April 15, 2021, 150 days after receiving the submission on November 16, 2020. This device falls under the Pathology review panel. Regulated under 21 CFR 864.3700.

Submission Details

510(k) Number	K203364 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	PSY — Whole Slide Imaging System
Device Class	Class II — 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).