Cleared Traditional

K013531 - QWIKSIM VIRTUAL SIMULATION SYSTEM

Also marketed or referenced as:
VERSION 2.00

K013531 is an FDA 510(k) clearance for QWIKSIM VIRTUAL SIMULATION SYSTEM, manufactured by Impac Medical Systems, Inc.. The device is a Class 2 Radiology device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K013531

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
Combination Product No
PCCP Authorized No
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.

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 Product Service, Inc.
MARK JOB

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 69
Devices cleared under the same product code (KPQ) and FDA review panel - the closest regulatory comparables to K013531.
ACUITY RADIATION THERAPY SIMULATOR
K023052 · Varian Medical Systems, Inc. · Oct 2002
EXOMIO, MODEL 1.1
K022219 · Medcom GmbH · Oct 2002
ADVANTAGE SIM 6.0
K021780 · General Electric Medical Systems · Jul 2002
SOMAVISION
K992751 · Varian Assoc., Inc. · Feb 2000
HELAX-IMCON, VERSION 1.0
K982857 · Helax AB · Nov 1998
IBU, INTEGRATED BRACHY THERAPY UNIT
K973848 · Nucletron Corp. · Jan 1998
K013531 · QWIKSIM VIRTUAL SIMULATION SYSTEM
Download PDF FDA Summary Impac Medical Systems…