Cleared Traditional

K980541 - BARCO MGD 521 5 MEGAPIXEL DIAGNOSTIC DISPLAY

K980541 is an FDA 510(k) clearance for BARCO MGD 521 5 MEGAPIXEL DIAGNOSTIC DI..., manufactured by Barco NV Display Systems. The device is a Class 1 Radiology device with product code LMD cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K980541 · Barco NV Display Systems · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
57d
Days
Class 1
Risk

K980541 is an FDA 510(k) clearance for the BARCO MGD 521 5 MEGAPIXEL DIAGNOSTIC DISPLAY. Classified as System, Digital Image Communications, Radiological (product code LMD), Class I - General Controls.

Submitted by Barco NV Display Systems (Chico, US). The FDA issued a Cleared decision on April 9, 1998 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2020 - the FDA radiology and imaging software oversight 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.

FDA 510(k) Submission Details - K980541

510(k) Number K980541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1998
Decision Date April 09, 1998
Days to Decision 57 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 107d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

LMD Device Classification - Class 1, General Controls

Product Code LMD System, Digital Image Communications, Radiological
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.2020
Definition A Medical Image Communications Device Provides Electronic Transfer Of Medical Image Data Between Medical Devices. It May Include A Physical Communications Medium, Modems, Interfaces, And A Communications Protocol. It May Provide Simple Image Review Software Functionality For Medical Image Processing And Manipulation, Such As Grayscale Window And Level, Zoom And Pan, User Delineated Geometric Measurements, Compression, Or User Added Image Annotations. The Device Does Not Perform Advanced Image Processing Or Complex Quantitative Functions.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LMD System, Digital Image Communications, Radiological

All 130
Devices cleared under the same product code (LMD) and FDA review panel - the closest regulatory comparables to K980541.
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K980541 · BARCO MGD 521 5 MEGAPIXEL DIAGNOSTIC DISPLAY
Download PDF FDA Summary Barco NV Display Syst…