Cleared Traditional

K020483 - ADVANTAGE WORKSTATION 4.1

K020483 is an FDA 510(k) clearance for ADVANTAGE WORKSTATION 4.1, manufactured by GE Medical Systems. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K020483 · GE Medical Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
15d
Days
Class 2
Risk

K020483 is an FDA 510(k) clearance for the ADVANTAGE WORKSTATION 4.1. 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 GE Medical Systems (Mount Prospect, US). The FDA issued a Cleared decision on February 28, 2002 after a review of 15 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 GE Medical Systems devices

FDA 510(k) Submission Details - K020483

510(k) Number K020483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2002
Decision Date February 28, 2002
Days to Decision 15 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 1203
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K020483.
MEDICAL LE
K020058 · Barco N.V. · Apr 2002
MFCD 118I
K020059 · Barco N.V. · Apr 2002
IMAGEDESK
K020061 · Barco N.V. · Apr 2002
CORONIS 3MP MEDICL FLAT PANEL DISPLAY SYSTEM
K013922 · Barco N.V. · Jan 2002
CAAS II QVA
K012475 · Pie Medical Imaging BV · Oct 2001
KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ACR SYSTEMS
K012155 · Eastman Kodak Company · Aug 2001