KPQ — System, Simulation, Radiation Therapy Class II
FDA Device Classification
Classification Details
- Product Code
- KPQ
- Device Class
- Class II
- Regulation Number
- 892.5840
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K132944 | ge hungary kft | ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION | March 14, 2014 |
| K132045 | ge hungary kft | ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS | September 4, 2013 |
| K101038 | acceletronics digital imaging | RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER | August 17, 2010 |
| K090706 | nucletron corporation | ONCENTRA SIMULATION 2.3 | June 15, 2009 |
| K083591 | ikoetech | IKOENGELO, VERSION 2 | December 29, 2008 |
| K072445 | nucletron | INTEGRATED BRACHYTHERAPY UNIT - DIGITAL | September 14, 2007 |
| K061006 | ikoetech | IKOENGELO | June 5, 2006 |
| K052361 | nucletron corporation | SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM | October 24, 2005 |
| K052345 | ge healthcare | ADVANTAGE SIM MD | September 14, 2005 |
| K033470 | nucletron corporation | SIMULIX EVOLUTION | February 4, 2004 |
| K033339 | varian medical systems | ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY | December 30, 2003 |
| K032550 | medcom | EXOMIO, MODEL 2.0 SP1 | September 25, 2003 |
| K023052 | varian medical systems | ACUITY RADIATION THERAPY SIMULATOR | October 11, 2002 |
| K022219 | medcom | EXOMIO, MODEL 1.1 | October 7, 2002 |
| K021780 | general electric medical systems | ADVANTAGE SIM 6.0 | July 29, 2002 |
| K013531 | impac medical systems | QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00 | November 7, 2001 |
| K992751 | varian assoc | SOMAVISION | February 16, 2000 |
| K982857 | helax | HELAX-IMCON, VERSION 1.0 | November 4, 1998 |
| K973848 | nucletron | IBU, INTEGRATED BRACHY THERAPY UNIT | January 22, 1998 |
| K971839 | varian medical systems | VARIAN RADIATION THERAPY IMAGING SYSTEM | August 15, 1997 |