The X-Ray Digitizer, Altek Model ACT20020-BL

FDA 510(k) K895442 · Altek Corp.

Substantially Equivalent

510(k) numberK895442

Submission

Device name
The X-Ray Digitizer, Altek Model ACT20020-BL
Applicant
Altek Corp.
Silver Spring, MD, US
Received
September 8, 1989
Decision date
December 14, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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

510(k)DeviceApplicantDecision
K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationKPQ · Traditional Ge Hungary Kft03/14/2014SE
K132045Advantagesim MD with CT Atlas-Based Contouring and Re-Planning OptionsKPQ · Traditional Ge Hungary Kft09/04/2013SE
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 The X-Ray Digitizer, Altek Model ACT20020-BL cleared by the FDA?

The X-Ray Digitizer, Altek Model ACT20020-BL (K895442) received a 510(k) decision of Substantially Equivalent on December 14, 1989, 97 days after the submission was received.

What is the product code of K895442?

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