Cleared Special

K090732 - NIO COLOR 3MP AND MDNC-3121

K090732 is an FDA 510(k) clearance for NIO COLOR 3MP AND MDNC-3121, manufactured by Barco N.V.. The device is a Class 2 Radiology device with product code LLZ cleared through the Special 510(k) pathway after a 32-day FDA review.

K090732 · Barco N.V. · Radiology device
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Apr 2009
Decision
32d
Days
Class 2
Risk

K090732 is an FDA 510(k) clearance for the NIO COLOR 3MP AND MDNC-3121. 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 N.V. (Kortrijk, BE). The FDA issued a Cleared decision on April 20, 2009 after a review of 32 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Incremental AI imaging tool. Low regulatory complexity profile. 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 N.V. devices

FDA 510(k) Submission Details - K090732

510(k) Number K090732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2009
Decision Date April 20, 2009
Days to Decision 32 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 107d · This submission: 32d
Pathway characteristics
Modification to existing cleared device.

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 1940
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K090732.
NIO 2MP (MDNG-2121)
K091172 · Barco N.V. · May 2009
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K090603 · Barco N.V. · Apr 2009
BLUE SKY BIO PLAN, VERSION .38
K090607 · Blue Sky Bio, LLC · Apr 2009
BRIT PACS SYSTEMS
K081168 · Brit Systems, Inc. · Mar 2009
UROCARE
K090552 · Neusoft Medical Systems Co., Ltd. · Mar 2009
MAMMODIAGNOST VU
K083740 · Philips Medical Systems Nederland B.V. · Feb 2009