# K013531: Qwiksim Virtual Simulation System; Version 2.00

- Pathway: 510(k) (Traditional)
- Applicant: Impac Medical Systems, Inc.
- Decided: Nov 7, 2001 after 15 days
- Product code: KPQ (System, Simulation, Radiation Therapy)
- Device class: 2
- Regulation: 21 CFR 892.5840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K923851 (1992). 3 ancestors in all.
307 later devices descend from it; 2 cite it directly.
1 of 311 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951830: Advantage Sim, General Electric Co. (1995) Summary page 1.
- K923851: Acqsim Simulator/Localizer, Philips Medical Systems (Cleveland), Inc. (1992) Summary page 2.
- K992751: Somavision, Varian Assoc., Inc. (2000) Summary page 2.

## Most influential descendants
- K061006: Ikoengelo (2006), 299 descendants of its own
- K071964: Mim 4.1 (Seastar) (2007), 287 descendants of its own
- K071950: Syngo Trued (2007), 201 descendants of its own
- K091373: Syngo Trued (2009), 200 descendants of its own
- K103576: Mim 5.2 (Brachy) (2011), 79 descendants of its own

## Indications for use
The QwikSIM Virtual Simulation System may be used by radiation oncologists, medical physicists, and medical dosimetrists for patient localization, image import and review, tumor and normal tissue delineation, and virtual simulation of treatment unit setup during the treatment planning process of external beam radiotherapy treatment. This information may then be exported to a treatment planning system for dose calculation.

Source page: https://510kreport.com/device/K013531
Methodology: https://510kreport.com/methodology