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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Tuv Rheinland of North America, Inc.
WOLFRAM GMELIN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KPQ System, Simulation, Radiation Therapy

All 64
Devices cleared under the same product code (KPQ) and FDA review panel - the closest regulatory comparables to K021780.
EXOMIO, MODEL 2.0 SP1
K032550 · Medcom GmbH · Sep 2003
ACUITY RADIATION THERAPY SIMULATOR
K023052 · Varian Medical Systems, Inc. · Oct 2002
EXOMIO, MODEL 1.1
K022219 · Medcom GmbH · Oct 2002
QWIKSIM VIRTUAL SIMULATION SYSTEM
K013531 · Impac Medical Systems, Inc. · Nov 2001
SOMAVISION
K992751 · Varian Assoc., Inc. · Feb 2000
HELAX-IMCON, VERSION 1.0
K982857 · Helax AB · Nov 1998
K021780 · ADVANTAGE SIM 6.0
Download PDF FDA Summary General Electric Medi…