Cleared Traditional

K013531 - QWIKSIM VIRTUAL SIMULATION SYSTEM

Also marketed or referenced as:
VERSION 2.00

K013531 is the FDA 510(k) clearance for QWIKSIM VIRTUAL SIMULATION SYSTEM by Impac Medical Systems, Inc.. It is a Class 2 Radiology device (product code KPQ) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K013531 · Impac Medical Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
15d
Days
Class 2
Risk

K013531 is an FDA 510(k) clearance for the QWIKSIM VIRTUAL SIMULATION SYSTEM. Classified as System, Simulation, Radiation Therapy (product code KPQ), Class II - Special Controls.

Submitted by Impac Medical Systems, Inc. (Mountain View, US). The FDA issued a Cleared decision on November 7, 2001 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5840 - 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 Impac Medical Systems, Inc. devices

Submission Details

510(k) Number K013531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2001
Decision Date November 07, 2001
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.

Device Classification

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 27
Devices cleared under the same product code (KPQ) and FDA review panel - the closest regulatory comparables to K013531.
ADVANTAGE SIM MD
K052345 · Ge Healthcare · Sep 2005
ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY
K033339 · Varian Medical Systems, Inc. · Dec 2003
ACUITY RADIATION THERAPY SIMULATOR
K023052 · Varian Medical Systems, Inc. · Oct 2002
SOMAVISION
K992751 · Varian Assoc., Inc. · Feb 2000
VARIAN RADIATION THERAPY IMAGING SYSTEM
K971839 · Varian Medical Systems, Inc. · Aug 1997
VARIAN XIMATRON C-SERIES RADIATION THERAPY SIMULATOR WITH VERSION 4.2 SOFTWARE
K964138 · Varian Medical Systems, Inc. · Jan 1997