Cleared Traditional

K951830 - ADVANTAGE SIM

K951830 is an FDA 510(k) clearance for ADVANTAGE SIM, manufactured by General Electric Co.. The device is a Class 2 Radiology device with product code KPQ cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K951830 · General Electric Co. · Radiology device
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Optimized for regulatory review, auditing and printing
Nov 1995
Decision
207d
Days
Class 2
Risk

K951830 is an FDA 510(k) clearance for the ADVANTAGE SIM. Classified as System, Simulation, Radiation Therapy (product code KPQ), Class II - Special Controls.

Submitted by General Electric Co. (Milwaukee, US). The FDA issued a Cleared decision on November 13, 1995 after a review of 207 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all General Electric Co. devices

FDA 510(k) Submission Details - K951830

510(k) Number K951830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1995
Decision Date November 13, 1995
Days to Decision 207 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
100d slower than avg
Panel avg: 107d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 40
Devices cleared under the same product code (KPQ) and FDA review panel - the closest regulatory comparables to K951830.
VARIAN XIMATRON C-SERIES RADIATION THERAPY SIMULATOR WITH VERSION 4.2 SOFTWARE
K964138 · Varian Medical Systems, Inc. · Jan 1997
SIMVIEW 3000 CT OPTION
K953233 · Siemens Medical Solutions USA, Inc. · Nov 1996
MODEL 555 010 XY CONVERSION(55010)
K960737 · Systems Supply Services, Inc. · May 1996
CTPORT CT SIMULATION SYSTEM FOR RADIOTHERAPY
K945838 · Toshiba America Medical Systems, In.C · Oct 1995
SIMVIEW(TM) 3000
K946053 · Siemens Medical Solutions USA, Inc. · Mar 1995
CMS RECORD AND VERIFY
K921108 · Computerized Medical Systems, Inc. · Nov 1992