Product code KPQ— Radiology
ACQSIM SIMULATOR/LOCALIZER
- Classification name
- System, Simulation, Radiation Therapy
- Device class
- Class 2
- Regulation
- 21 CFR 892.5840
- Advisory panel
- Radiology
- Total cleared
- 70
- First cleared
- Most recent
Market context for product code KPQ
FDA has cleared devices under product code KPQ between 1976 and 2014, filed by 46 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2014
- 2013
- 2010
- 2009
- 2008
- 2007
- 2006
- 2005
- 2004
- 2003
- 2002
- 2001
- 2000
- 1998
- 1997
Top applicants under product code KPQ
Recent clearances under product code KPQ
- K132944 — ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION
- K132045 — ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS
- K101038 — RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER
- K090706 — ONCENTRA SIMULATION 2.3
- K083591 — IKOENGELO, VERSION 2
- K072445 — INTEGRATED BRACHYTHERAPY UNIT - DIGITAL
- K061006 — IKOENGELO
- K052361 — SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM
- K052345 — ADVANTAGE SIM MD
- K033470 — SIMULIX EVOLUTION
- K033339 — ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY
- K032550 — EXOMIO, MODEL 2.0 SP1
- K023052 — ACUITY RADIATION THERAPY SIMULATOR
- K022219 — EXOMIO, MODEL 1.1
- K021780 — ADVANTAGE SIM 6.0
- K013531 — QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00
- K992751 — SOMAVISION
- K982857 — HELAX-IMCON, VERSION 1.0
- K973848 — IBU, INTEGRATED BRACHY THERAPY UNIT
- K971839 — VARIAN RADIATION THERAPY IMAGING SYSTEM
- K964972 — SHADOWFORM
- K964138 — VARIAN XIMATRON C-SERIES RADIATION THERAPY SIMULATOR WITH VERSION 4.2 SOFTWARE
- K953233 — SIMVIEW 3000 CT OPTION
- K960737 — MODEL 555 010 XY CONVERSION(55010)
- K951830 — ADVANTAGE SIM
- K945838 — CTPORT CT SIMULATION SYSTEM FOR RADIOTHERAPY
- K946128 — SIMULIX-HP
- K946053 — SIMVIEW(TM) 3000
- K930213 — MODEL ASYM-100
- K921108 — CMS RECORD AND VERIFY
- K923851 — ACQSIM SIMULATOR/LOCALIZER
- K922287 — E.Z. PORT(TM) RADIATION THERAPY SKIN MARKERS
- K920506 — CONTOURING DEVICE
- K921876 — MKS BEAM OUTLINE PROJECTOR
- K914926 — SCANDIPLAN - VERSION 338
- K913017 — MODULEX RTP SYSTEM
- K903313 — RAHD 3100
- K910647 — XIMATRON/CT OPTION
- K911340 — AUTOCOMP
- K912466 — OLDELFT SIMULIX-MC
- K910367 — COMPUTE-RX-COMP (TM)
- K896555 — CTS COMPUTED TOMOGRAPHY (CT) ATTACHMENT
- K894568 — NEW RAD-8 TREATMENT PLANNING COMPUTER SYSTEM
- K896353 — GE TARGET SERIES 2
- K895442 — THE X-RAY DIGITIZER, ALTEK MODEL ACT20020-BL
- K884261 — PROWESS 2000
- K891293 — SLS SIMULATOR (MODELS SLS-9 AND SLS-14)
- K884323 — XIMAVIEW(TM)
- K885081 — SIMRITE VERIFICATION AND SIMULATION SYSTEM
- K873580 — MHTI CT-SIM RADIATION THERAPY TREATMENT SIMULATOR
- K870221 — T.O.P. 2000 (TOMOGRAPHIC ORIENTATED PLANNING)
- K853671 — BEAMSCAN
- K854880 — RADIATION BEAM DATA ACQUISTIOIN SYSTEMS
- K852410 — MEVAPLAN AND SOMADOS
- K853349 — VARIAN XIMATRON C-SERIES RADIOTHERAPY TREATMENT ST
- K851813 — THERPAC-RADIATION THERAPY TREATMENT PLANNING SYSTE
- K850977 — COMPUTE RX-PLAN
- K851653 — VARIAN/XIMATRON 5 CARBON-FIBER COUCH TOP
- K834281 — RAD II SIMULATOR
- K812726 — KERMATH THERAPY SIMULATOR
- K810858 — XIMATRON V
- K803032 — PFIZER PZ-SLM RAD. THERAPY TRTMT. SIMUL.
- K803124 — SIDOS U.
- K782005 — RADIATION ONCOLOGY SYSTEM
- K781496 — XIMATRON IV
- K781519 — EMI SIMULATOR REMOTE CONTROL CONSOLE
- K780963 — X-RAY SYSTEM
- K770202 — CTM (CLINAC TREATMENT MONITOR)
- K761265 — VARIPLAN COMPUT. RADIOTHERAPY
- K760420 — FILTER, VACUUM LINE LINEGUARD
Data sourced from openFDA. This site is unofficial and independent of the FDA.