Cleared Traditional

K052345 - ADVANTAGE SIM MD

K052345 is an FDA 510(k) clearance for ADVANTAGE SIM MD, manufactured by Ge Healthcare. The device is a Class 2 Radiology device with product code KPQ cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K052345 · Ge Healthcare · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
19d
Days
Class 2
Risk

K052345 is an FDA 510(k) clearance for the ADVANTAGE SIM MD. Classified as System, Simulation, Radiation Therapy (product code KPQ), Class II - Special Controls.

Submitted by Ge Healthcare (Waukesha, US). The FDA issued a Cleared decision on September 14, 2005 after a review of 19 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 Ge Healthcare devices

FDA 510(k) Submission Details - K052345

510(k) Number K052345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2005
Decision Date September 14, 2005
Days to Decision 19 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
88d faster than avg
Panel avg: 107d · This submission: 19d
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

Intertek Testing Services
DANIEL W LEHTONEN

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 40
Devices cleared under the same product code (KPQ) and FDA review panel - the closest regulatory comparables to K052345.
INTEGRATED BRACHYTHERAPY UNIT - DIGITAL
K072445 · Nucletron Corp. · Sep 2007
IKOENGELO
K061006 · Ikoetech, LLC · Jun 2006
SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM
K052361 · Nucletron Corporation · Oct 2005
SIMULIX EVOLUTION
K033470 · Nucletron Corporation · Feb 2004
ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY
K033339 · Varian Medical Systems, Inc. · Dec 2003
ACUITY RADIATION THERAPY SIMULATOR
K023052 · Varian Medical Systems, Inc. · Oct 2002