KPQ · System, Simulation, Radiation Therapy
Radiology · 21 CFR 892.5840 · Class 2
Overview
| Product Code | KPQ |
|---|---|
| Device Name | System, Simulation, Radiation Therapy |
| Regulation | 21 CFR 892.5840 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
Identification
A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 70)
Showing 20 most recent of 70 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K132944 | ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION | Ge Hungary Kft | Mar 14, 2014 | SESE |
| K132045 | ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS | Ge Hungary Kft | Sep 4, 2013 | SESE |
| K101038 | RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER | Acceletronics Digital Imaging, LLC | Aug 17, 2010 | SESE |
| K090706 | ONCENTRA SIMULATION 2.3 | Nucletron Corporation | Jun 15, 2009 | SESE |
| K083591 | IKOENGELO, VERSION 2 | Ikoetech, LLC | Dec 29, 2008 | SESE |
| K072445 | INTEGRATED BRACHYTHERAPY UNIT - DIGITAL | Nucletron Corp. | Sep 14, 2007 | SESE |
| K061006 | IKOENGELO | Ikoetech, LLC | Jun 5, 2006 | SESE |
| K052361 | SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM | Nucletron Corporation | Oct 24, 2005 | SESE |
| K052345 | ADVANTAGE SIM MD | GE Healthcare | Sep 14, 2005 | SESE |
| K033470 | SIMULIX EVOLUTION | Nucletron Corporation | Feb 4, 2004 | SESE |
| K033339 | ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY | Varian Medical Systems, Inc. | Dec 30, 2003 | SESE |
| K032550 | EXOMIO, MODEL 2.0 SP1 | Medcom GmbH | Sep 25, 2003 | SESE |
| K023052 | ACUITY RADIATION THERAPY SIMULATOR | Varian Medical Systems, Inc. | Oct 11, 2002 | SESE |
| K022219 | EXOMIO, MODEL 1.1 | Medcom GmbH | Oct 7, 2002 | SESE |
| K021780 | ADVANTAGE SIM 6.0 | General Electric Medical Systems | Jul 29, 2002 | SESE |
| K013531 | QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00 | Impac Medical Systems, Inc. | Nov 7, 2001 | SESE |
| K992751 | SOMAVISION | Varian Assoc., Inc. | Feb 16, 2000 | SESE |
| K982857 | HELAX-IMCON, VERSION 1.0 | Helax AB | Nov 4, 1998 | SESE |
| K973848 | IBU, INTEGRATED BRACHY THERAPY UNIT | Nucletron Corp. | Jan 22, 1998 | SESE |
| K971839 | VARIAN RADIATION THERAPY IMAGING SYSTEM | Varian Medical Systems, Inc. | Aug 15, 1997 | SESE |
Top Applicants
- Varian Assoc., Inc. — 6 clearances
- Varian Medical Systems, Inc. — 4 clearances
- Computerized Medical Systems, Inc. — 3 clearances
- Nucletron Corporation — 3 clearances
- Siemens Medical Solutions USA, Inc. — 3 clearances
