Simulix-Hp
FDA 510(k) K946128 · Oldelft Corp. of America
510(k) numberK946128
Submission
- Device name
- Simulix-Hp
- Applicant
- Oldelft Corp. of America
Fairfax, VA, US - Received
- December 15, 1994
- Decision date
- May 12, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| 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 |
| 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 |
More from Nucletron Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K980296 | Oldelft DigidelcaKPR · Traditional | 04/17/1998SE |
| K973219 | Amber duKPR · Traditional | 10/08/1997SE |
| K950037 | N 800 HFIZO · Traditional | 02/15/1995SE |
| K932848 | Simulix-Mc CT ExtensionJAK · Traditional | 03/22/1994SE |
| K923584 | Therapax DXT 300 Series 3JAD · Traditional | 01/15/1993SE |
| K914784 | Papillion ProctoscopeKQA · Traditional | 06/05/1992SE |
| K912466 | Oldelft Simulix-McKPQ · Traditional | 06/28/1991SE |
| K892659 | ElectrodelcaIZG · Traditional | 11/21/1989SE |
Questions and answers
When was Simulix-Hp cleared by the FDA?
Simulix-Hp (K946128) received a 510(k) decision of Substantially Equivalent on May 12, 1995, 148 days after the submission was received.
What is the product code of K946128?
The FDA product code is KPQ – System, Simulation, Radiation Therapy, a Class II (moderate risk) device regulated under 21 CFR 892.5840.