Model ASYM-100

FDA 510(k) K930213 · Nucletron Mfg. Corp.

Substantially Equivalent

510(k) numberK930213

Submission

Device name
Model ASYM-100
Applicant
Nucletron Mfg. Corp.
Urbana, VA, US
Received
January 15, 1993
Decision date
September 7, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
KPQ – System, Simulation, Radiation Therapy
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5840
Specialty
Radiology

Other 510(k)s with product code KPQ

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K101038Rad II Simulator, Rad II KV Imager, Dual Rad II KV ImagerKPQ · Traditional Acceletronics Digital Imaging, LLC08/17/2010SE
K090706Oncentra Simulation 2.3KPQ · Traditional Nucletron Corporation06/15/2009SE
K083591Ikoengelo, Version 2KPQ · Special Ikoetech, LLC12/29/2008SE
K072445Integrated Brachytherapy Unit - DigitalKPQ · Special Nucletron Corp.09/14/2007SE
K061006IkoengeloKPQ · Traditional Ikoetech, LLC06/05/2006SE
K052361Simulix-Evolution with Oncentra ConebeamKPQ · Special Nucletron Corporation10/24/2005SE
K052345Advantage Sim MDKPQ · Traditional GE Healthcare09/14/2005SE
K033470Simulix EvolutionKPQ · Special Nucletron Corporation02/04/2004SE

Questions and answers

When was Model ASYM-100 cleared by the FDA?

Model ASYM-100 (K930213) received a 510(k) decision of Substantially Equivalent on September 7, 1993, 235 days after the submission was received.

What is the product code of K930213?

The FDA product code is KPQ – System, Simulation, Radiation Therapy, a Class II (moderate risk) device regulated under 21 CFR 892.5840.