Autocomp
FDA 510(k) K911340 · Victoreen, Inc.
510(k) numberK911340
Submission
- Device name
- Autocomp
- Applicant
- Victoreen, Inc.
Carle Place, NY, US - Received
- March 26, 1991
- Decision date
- August 26, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code KPQ
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|---|---|---|---|
| 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 |
| 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 |
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| K973960 | Model 37-185LHN · Traditional | 01/14/1998SE |
| K964952 | Veridose V (Five), Model Number 37-705JAD · Traditional | 07/21/1997SE |
| K964785 | Veridose DiodesIYE · Traditional | 06/13/1997SE |
| K971382 | Prone Breast Positioning Board, Model #37-018IYE · Traditional | 06/06/1997SE |
| K952233 | Clear-Pb Lead Plastic Overhead Barrier 56-628EAK · Traditional | 06/16/1995SE |
| K940660 | Model 37-720 Dual Diode Dosimetry SystemIYE · Traditional | 12/09/1994SE |
| K935435 | Nuclear Assoc 37-08 Ser, Raycast HP Radio Immob SystIYE · Traditional | 07/29/1994SE |
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Questions and answers
When was Autocomp cleared by the FDA?
Autocomp (K911340) received a 510(k) decision of Substantially Equivalent on August 26, 1991, 153 days after the submission was received.
What is the product code of K911340?
The FDA product code is KPQ – System, Simulation, Radiation Therapy, a Class II (moderate risk) device regulated under 21 CFR 892.5840.