Rad II Simulator, Rad II KV Imager, Dual Rad II KV Imager
FDA 510(k) K101038 · Acceletronics Digital Imaging, LLC
510(k) numberK101038
Submission
- Device name
- Rad II Simulator, Rad II KV Imager, Dual Rad II KV Imager
- Applicant
- Acceletronics Digital Imaging, LLC
Exton, PA, US - Received
- April 14, 2010
- Decision date
- August 17, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| K090706 | Oncentra Simulation 2.3KPQ · Traditional | Nucletron Corporation | 06/15/2009SE |
| K083591 | Ikoengelo, Version 2KPQ · Special | Ikoetech, LLC | 12/29/2008SE |
| 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 |
Questions and answers
When was Rad II Simulator, Rad II KV Imager, Dual Rad II KV Imager cleared by the FDA?
Rad II Simulator, Rad II KV Imager, Dual Rad II KV Imager (K101038) received a 510(k) decision of Substantially Equivalent on August 17, 2010, 125 days after the submission was received.
What is the product code of K101038?
The FDA product code is KPQ – System, Simulation, Radiation Therapy, a Class II (moderate risk) device regulated under 21 CFR 892.5840.