KPQ — System, Simulation, Radiation Therapy Class II
FDA product code KPQ covers "System, Simulation, Radiation Therapy", a Class II medical device regulated under 21 CFR 892.5840. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |