System, Simulation, Radiation Therapy

FDA product code KPQ · 69 cleared devices

Class 2 Radiology

Regulation: 21 CFR 892.5840
Review panel: RA
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-08-23 – 2013-09-04

KPQ 2013-09-04

ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS

Applicant Ge Hungary Kft

K number K132045

View details →

KPQ 2010-08-17

RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER

Applicant Acceletronics Digital Imaging, LLC

K number K101038

View details →

KPQ 2009-06-15

ONCENTRA SIMULATION 2.3

Applicant Nucletron Corporation

K number K090706

View details →

KPQ 2008-12-29

IKOENGELO, VERSION 2

Applicant Ikoetech, LLC

K number K083591

View details →

KPQ 2007-09-14

INTEGRATED BRACHYTHERAPY UNIT - DIGITAL

Applicant Nucletron Corp.

K number K072445

View details →

KPQ 2006-06-05

IKOENGELO

Applicant Ikoetech, LLC

K number K061006

View details →

KPQ 2005-10-24

SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM

Applicant Nucletron Corporation

K number K052361

View details →

KPQ 2005-09-14

ADVANTAGE SIM MD

Applicant GE Healthcare

K number K052345

View details →

KPQ 2004-02-04

SIMULIX EVOLUTION

Applicant Nucletron Corporation

K number K033470

View details →

KPQ 2003-12-30

ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY

Applicant Varian Medical Systems, Inc.

K number K033339

View details →

KPQ 2003-09-25

EXOMIO, MODEL 2.0 SP1

Applicant Medcom GmbH

K number K032550

View details →

KPQ 2002-10-11

ACUITY RADIATION THERAPY SIMULATOR

Applicant Varian Medical Systems, Inc.

K number K023052

View details →

KPQ 2002-10-07

EXOMIO, MODEL 1.1

Applicant Medcom GmbH

K number K022219

View details →

KPQ 2002-07-29

ADVANTAGE SIM 6.0

Applicant General Electric Medical Systems

K number K021780

View details →

KPQ 2001-11-07

QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00

Applicant Impac Medical Systems, Inc.

K number K013531

View details →

KPQ 2000-02-16

SOMAVISION

Applicant Varian Assoc., Inc.

K number K992751

View details →

KPQ 1998-11-04

HELAX-IMCON, VERSION 1.0

Applicant Helax AB

K number K982857

View details →

KPQ 1998-01-22

IBU, INTEGRATED BRACHY THERAPY UNIT

Applicant Nucletron Corp.

K number K973848

View details →

KPQ 1997-08-15

VARIAN RADIATION THERAPY IMAGING SYSTEM

Applicant Varian Medical Systems, Inc.

K number K971839

View details →

KPQ 1997-05-05

SHADOWFORM

Applicant I.Z.I. Medical Products Corp.

K number K964972

View details →

KPQ 1997-01-10

VARIAN XIMATRON C-SERIES RADIATION THERAPY SIMULATOR WITH VERSION 4.2 SOFTWARE

Applicant Varian Medical Systems, Inc.

K number K964138

View details →

KPQ 1996-11-29

SIMVIEW 3000 CT OPTION

Applicant Siemens Medical Solutions USA, Inc.

K number K953233

View details →

KPQ 1996-05-22

MODEL 555 010 XY CONVERSION(55010)

Applicant Systems Supply Services, Inc.

K number K960737

View details →

KPQ 1995-11-13

ADVANTAGE SIM

Applicant General Electric Co.

K number K951830

View details →

KPQ 1995-10-25

CTPORT CT SIMULATION SYSTEM FOR RADIOTHERAPY

Applicant Toshiba America Medical Systems, In.C

K number K945838

View details →

KPQ 1995-05-12

SIMULIX-HP

Applicant Oldelft Corp. of America

K number K946128

View details →

KPQ 1995-03-31

SIMVIEW(TM) 3000

Applicant Siemens Medical Solutions USA, Inc.

K number K946053

View details →

KPQ 1993-09-07

MODEL ASYM-100

Applicant Nucletron Mfg. Corp.

K number K930213

View details →

KPQ 1992-11-02

CMS RECORD AND VERIFY

Applicant Computerized Medical Systems, Inc.

K number K921108

View details →

KPQ 1992-10-27

ACQSIM SIMULATOR/LOCALIZER

Applicant Philips Medical Systems (Cleveland), Inc.

K number K923851

View details →

KPQ 1992-10-16

E.Z. PORT(TM) RADIATION THERAPY SKIN MARKERS

Applicant I.Z.I. Corp.

K number K922287

View details →

KPQ 1992-10-14

CONTOURING DEVICE

Applicant X-Icon Medical Systems

K number K920506

View details →

KPQ 1992-06-25

MKS BEAM OUTLINE PROJECTOR

Applicant Medical Knowledge Systems, Inc.

K number K921876

View details →

KPQ 1992-05-28

SCANDIPLAN - VERSION 338

Applicant Scanditronix, Inc.

K number K914926

View details →

KPQ 1991-10-17

MODULEX RTP SYSTEM

Applicant Computerized Medical Systems, Inc.

K number K913017

View details →

KPQ 1991-10-07

RAHD 3100

Applicant Esm , Ltd.

K number K903313

View details →

KPQ 1991-09-19

XIMATRON/CT OPTION

Applicant Fischer Imaging Corp.

K number K910647

View details →

KPQ 1991-08-26

AUTOCOMP

Applicant Victoreen, Inc.

K number K911340

View details →

KPQ 1991-06-28

OLDELFT SIMULIX-MC

Applicant Oldelft Corp. of America

K number K912466

View details →

KPQ 1991-05-30

COMPUTE-RX-COMP (TM)

Applicant Medicalibration Physics Consultant Services, Inc.

K number K910367

View details →

KPQ 1990-04-26

CTS COMPUTED TOMOGRAPHY (CT) ATTACHMENT

Applicant W. L. Systems, Inc.

K number K896555

View details →

KPQ 1990-01-09

NEW RAD-8 TREATMENT PLANNING COMPUTER SYSTEM

Applicant Advanced Medical Systems, Inc.

K number K894568

View details →

KPQ 1989-12-22

GE TARGET SERIES 2

Applicant GE Medical Systems

K number K896353

View details →

KPQ 1989-12-14

THE X-RAY DIGITIZER, ALTEK MODEL ACT20020-BL

Applicant Altek Corp.

K number K895442

View details →

KPQ 1989-08-04

PROWESS 2000

Applicant Small Systems Group, Inc.

K number K884261

View details →

KPQ 1989-04-20

SLS SIMULATOR (MODELS SLS-9 AND SLS-14)

Applicant Philips Medical Systems North America, Inc.

K number K891293

View details →

KPQ 1989-04-03

XIMAVIEW(TM)

Applicant Varian Assoc., Inc.

K number K884323

View details →

KPQ 1989-03-22

SIMRITE VERIFICATION AND SIMULATION SYSTEM

Applicant Haynes Radiation Ltd., Inc.

K number K885081

View details →

KPQ 1987-11-02

MHTI CT-SIM RADIATION THERAPY TREATMENT SIMULATOR

Applicant Medical High Technology International, Inc.

K number K873580

View details →

KPQ 1987-05-12

T.O.P. 2000 (TOMOGRAPHIC ORIENTATED PLANNING)

Applicant Kermath Mfg. Corp.

K number K870221

View details →

KPQ 1986-01-10

RADIATION BEAM DATA ACQUISTIOIN SYSTEMS

Applicant Computerized Medical Systems, Inc.

K number K854880

View details →

KPQ 1986-01-10

BEAMSCAN

Applicant Victoreen, Inc.

K number K853671

View details →

KPQ 1985-10-28

VARIAN XIMATRON C-SERIES RADIOTHERAPY TREATMENT ST

Applicant Varian Assoc., Inc.

K number K853349

View details →

KPQ 1985-10-28

MEVAPLAN AND SOMADOS

Applicant Siemens Medical Solutions USA, Inc.

K number K852410

View details →

KPQ 1985-08-07

THERPAC-RADIATION THERAPY TREATMENT PLANNING SYSTE

Applicant Victoreen, Inc.

K number K851813

View details →

KPQ 1985-07-26

COMPUTE RX-PLAN

Applicant Medicalibration

K number K850977

View details →

KPQ 1985-05-23

VARIAN/XIMATRON 5 CARBON-FIBER COUCH TOP

Applicant Varian Assoc., Inc.

K number K851653

View details →

KPQ 1983-12-29

RAD II SIMULATOR

Applicant Haynes Radiation Ltd., Inc.

K number K834281

View details →

KPQ 1981-11-05

KERMATH THERAPY SIMULATOR

Applicant Kermath Mfg. Corp.

K number K812726

View details →

KPQ 1981-05-13

XIMATRON V

Applicant Siemens Corp.

K number K810858

View details →

KPQ 1981-01-22

SIDOS U.

Applicant Siemens Corp.

K number K803124

View details →

KPQ 1981-01-22

PFIZER PZ-SLM RAD. THERAPY TRTMT. SIMUL.

Applicant Pfizer Medical Systems, Inc.

K number K803032

View details →

KPQ 1978-12-20

RADIATION ONCOLOGY SYSTEM

Applicant Adac Laboratories

K number K782005

View details →

KPQ 1978-09-14

EMI SIMULATOR REMOTE CONTROL CONSOLE

Applicant Emi Medical, Inc.

K number K781519

View details →

KPQ 1978-09-14

XIMATRON IV

Applicant Siemens Elema AB

K number K781496

View details →

KPQ 1978-06-27

X-RAY SYSTEM

Applicant General X-Ray, Inc.

K number K780963

View details →

KPQ 1977-02-07

CTM (CLINAC TREATMENT MONITOR)

Applicant Varian Assoc., Inc.

K number K770202

View details →

KPQ 1976-12-21

VARIPLAN COMPUT. RADIOTHERAPY

Applicant Varian Assoc., Inc.

K number K761265

View details →

KPQ 1976-08-23

FILTER, VACUUM LINE LINEGUARD

Applicant Diemolding Corp.

K number K760420

View details →