Cleared Traditional

K033104 - MGD 2621P MEDICAL GREYSCALE DISPLAY

K033104 is an FDA 510(k) clearance for MGD 2621P MEDICAL GREYSCALE DISPLAY, 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 203-day FDA review.

K033104 · Barco NV Barcoview · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
203d
Days
Class 2
Risk

K033104 is an FDA 510(k) clearance for the MGD 2621P MEDICAL GREYSCALE DISPLAY. 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 April 19, 2004 after a review of 203 days - an extended review 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-to-high 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.

FDA 510(k) Submission Details - K033104

510(k) Number K033104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2003
Decision Date April 19, 2004
Days to Decision 203 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
96d slower than avg
Panel avg: 107d · This submission: 203d
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 2285
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K033104.
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K033104 · MGD 2621P MEDICAL GREYSCALE DISPLAY
Download PDF FDA Summary Barco NV Barcoview