Cleared Traditional

K040040 - NIO 5MP MEDICAL GRAYSCALE DISPLAY SYSTEM

K040040 is an FDA 510(k) clearance for NIO 5MP MEDICAL GRAYSCALE DISPLAY SYSTEM, manufactured by Barco NV Barcoview. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K040040 · Barco NV Barcoview · Radiology device
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Mar 2004
Decision
80d
Days
Class 2
Risk

K040040 is an FDA 510(k) clearance for the NIO 5MP MEDICAL GRAYSCALE DISPLAY SYSTEM. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Barco NV Barcoview (Albuquerque, US). The FDA issued a Cleared decision on March 29, 2004 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Barco NV Barcoview devices

FDA 510(k) Submission Details - K040040

510(k) Number K040040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2004
Decision Date March 29, 2004
Days to Decision 80 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 107d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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 Radiology devices follow this clearance model.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 1498
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K040040.
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