Cleared Traditional

K021780 - ADVANTAGE SIM 6.0

K021780 is an FDA 510(k) clearance for ADVANTAGE SIM 6.0, manufactured by General Electric Medical Systems. The device is a Class 2 Radiology device with product code KPQ cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K021780 · General Electric Medical Systems · Radiology device
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Jul 2002
Decision
60d
Days
Class 2
Risk

K021780 is an FDA 510(k) clearance for the ADVANTAGE SIM 6.0. Classified as System, Simulation, Radiation Therapy (product code KPQ), Class II - Special Controls.

Submitted by General Electric Medical Systems (Waukesha, US). The FDA issued a Cleared decision on July 29, 2002 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5840 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all General Electric Medical Systems devices

FDA 510(k) Submission Details - K021780

510(k) Number K021780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2002
Decision Date July 29, 2002
Days to Decision 60 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
47d faster than avg
Panel avg: 107d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

KPQ Device Classification - Class 2, Special Controls

Product Code KPQ System, Simulation, Radiation Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5840
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 - KPQ System, Simulation, Radiation Therapy

All 38
Devices cleared under the same product code (KPQ) and FDA review panel - the closest regulatory comparables to K021780.
SIMULIX EVOLUTION
K033470 · Nucletron Corporation · Feb 2004
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K033339 · Varian Medical Systems, Inc. · Dec 2003
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K023052 · Varian Medical Systems, Inc. · Oct 2002
SOMAVISION
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HELAX-IMCON, VERSION 1.0
K982857 · Helax AB · Nov 1998
IBU, INTEGRATED BRACHY THERAPY UNIT
K973848 · Nucletron Corp. · Jan 1998