Integrated Brachytherapy Unit - Digital
FDA 510(k) K072445 · Nucletron Corp.
510(k) numberK072445
Submission
- Device name
- Integrated Brachytherapy Unit - Digital
- Applicant
- Nucletron Corp.
Columbia, MD, US - Received
- August 30, 2007
- Decision date
- September 14, 2007
- 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 |
| K083591 | Ikoengelo, Version 2KPQ · Special | Ikoetech, LLC | 12/29/2008SE |
| 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 |
|---|---|---|
| K113102 | Oncentra Manual Low Dose Rate Treatment PlanningMUJ · Traditional | 12/12/2011SE |
| K112420 | Oncentra Prostate 4.0JAQ · Traditional | 11/18/2011SE |
| K111973 | Vaginal CT / MR Multi Channel Applicator SetJAQ · Special | 09/21/2011SE |
| K103515 | Equal DoseMUJ · Traditional | 09/15/2011SE |
| K092804 | Microselectron HDR V2, Model 105.999JAQ · Special | 10/08/2009SE |
| K091598 | Lumencath Applicator Set, Models 189. 795, 189.796, 189.797, 189.798, Lumencath CathetersJAQ · Special | 06/29/2009SE |
| K090706 | Oncentra Simulation 2.3KPQ · Traditional | 06/15/2009SE |
| K091154 | Utrecht Interstitial Fletcher Ct/Mr Applicator Set, Model 110.270, Interstitial Ring…JAQ · Special | 05/18/2009SE |
| K082642 | Oncentra RT Viewer 1.0MUJ · Traditional | 11/07/2008SE |
| K080934 | Vienna Ring Ct/Mr Applicator Set, Round Point Titanium Needle Set, Trocar Point Titanium…JAQ · Traditional | 05/28/2008SE |
Questions and answers
When was Integrated Brachytherapy Unit - Digital cleared by the FDA?
Integrated Brachytherapy Unit - Digital (K072445) received a 510(k) decision of Substantially Equivalent on September 14, 2007, 15 days after the submission was received.
What is the product code of K072445?
The FDA product code is KPQ – System, Simulation, Radiation Therapy, a Class II (moderate risk) device regulated under 21 CFR 892.5840.