Ikoengelo, Version 2
FDA 510(k) K083591 · Ikoetech, LLC
510(k) numberK083591
Submission
- Device name
- Ikoengelo, Version 2
- Applicant
- Ikoetech, LLC
Houston, TX, US - Received
- December 4, 2008
- Decision date
- December 29, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code KPQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K132944 | Advantagesim MD MR Pelvic Organ at Risk SegmentationKPQ · Traditional | Ge Hungary Kft | 03/14/2014SE |
| K132045 | Advantagesim MD with CT Atlas-Based Contouring and Re-Planning OptionsKPQ · Traditional | Ge Hungary Kft | 09/04/2013SE |
| K101038 | Rad II Simulator, Rad II KV Imager, Dual Rad II KV ImagerKPQ · Traditional | Acceletronics Digital Imaging, LLC | 08/17/2010SE |
| K090706 | Oncentra Simulation 2.3KPQ · Traditional | Nucletron Corporation | 06/15/2009SE |
| K072445 | Integrated Brachytherapy Unit - DigitalKPQ · Special | Nucletron Corp. | 09/14/2007SE |
| K061006 | IkoengeloKPQ · Traditional | Ikoetech, LLC | 06/05/2006SE |
| K052361 | Simulix-Evolution with Oncentra ConebeamKPQ · Special | Nucletron Corporation | 10/24/2005SE |
| K052345 | Advantage Sim MDKPQ · Traditional | GE Healthcare | 09/14/2005SE |
| K033470 | Simulix EvolutionKPQ · Special | Nucletron Corporation | 02/04/2004SE |
| K033339 | Acuity with Conebeam Computed TomographyKPQ · Traditional | Varian Medical Systems, Inc. | 12/30/2003SE |
More from Varian Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K061006 | IkoengeloKPQ · Traditional | 06/05/2006SE |
Questions and answers
When was Ikoengelo, Version 2 cleared by the FDA?
Ikoengelo, Version 2 (K083591) received a 510(k) decision of Substantially Equivalent on December 29, 2008, 25 days after the submission was received.
What is the product code of K083591?
The FDA product code is KPQ – System, Simulation, Radiation Therapy, a Class II (moderate risk) device regulated under 21 CFR 892.5840.