Cleared Traditional

K022773 - BARCO MEDIS 2MP1NT MEDICAL DIAGNOSTIC D...

K022773 is the FDA 510(k) clearance for BARCO MEDIS 2MP1NT MEDICAL DIAGNOSTIC D... by Barco N.V.. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K022773 · Barco N.V. · Radiology device
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Dec 2002
Decision
114d
Days
Class 2
Risk

K022773 is an FDA 510(k) clearance for the BARCO MEDIS 2MP1NT MEDICAL DIAGNOSTIC 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 13, 2002 after a review of 114 days - within the typical 510(k) review window.

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 K022773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2002
Decision Date December 13, 2002
Days to Decision 114 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
7d slower than avg
Panel avg: 107d · This submission: 114d
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 K022773.
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K023341 · Barco N.V. · Dec 2002
Q LAB QUANTIFICATION SOFTWARE WITH STRAIN RATE QUANTIFICATION PLUG-IN
K023877 · Philips Ultrasound, Inc. · Dec 2002
KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
K023772 · Acuson Corp. · Nov 2002
CENTRICITY PACS PLUS
K023557 · GE Medical Systems · Nov 2002
PHILIPS DIGITAL IMAGING OPTION RELEASE 1
K023440 · Philips Medical Systems · Oct 2002