Cleared Traditional

K023322 - CORONIS 2MP MEDICAL FLAT PANEL DISPLAY ...

K023322 is the FDA 510(k) clearance for CORONIS 2MP MEDICAL FLAT PANEL DISPLAY ... by Barco N.V.. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K023322 · Barco N.V. · Radiology device
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Dec 2002
Decision
80d
Days
Class 2
Risk

K023322 is an FDA 510(k) clearance for the CORONIS 2MP MEDICAL FLAT PANEL 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 N.V. (La Jolla, US). The FDA issued a Cleared decision on December 23, 2002 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 N.V. devices

Submission Details

510(k) Number K023322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2002
Decision Date December 23, 2002
Days to Decision 80 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
27d faster than avg
Panel avg: 107d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 1132
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K023322.
STRYKERWARE SYSTEM
K024159 · Stryker Endoscopy · Mar 2003
BARCO MEDIS 5MP2 AURA
K023533 · Barco N.V. · Jan 2003
JUPITER PROCESSING AND REVIEW WORKSTATION
K024137 · Ge Medical Systems, Inc. · Jan 2003
IMAGETILE
K023339 · Barco N.V. · Dec 2002
CORONIS 1MP MEDICAL FLAT PANEL DISPLAY SYSTEM
K023340 · Barco N.V. · Dec 2002
CORNIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM
K023341 · Barco N.V. · Dec 2002