Atlas FDA

KPQ

70 FDA 510(k) clearances · Product code

89 daysmedian time to decision
235 days90th percentile
70clearances measured

FDA profile

Official device name
System, Simulation, Radiation Therapy
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5840
Medical specialty
Radiology
Flags
Third-party review eligible
Adverse events (MAUDE)
2007: 17 · 2008: 12 · 2009: 7 · 2010: 10 · 2011: 12 · 2012: 11
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION (K132944)Ge Hungary Kft2014-03-14
ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS (K132045)Ge Hungary Kft2013-09-04
RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER (K101038)Acceletronics Digital Imaging, LLC2010-08-17
ONCENTRA SIMULATION 2.3 (K090706)Nucletron Corporation2009-06-15
IKOENGELO, VERSION 2 (K083591)Ikoetech, LLC2008-12-29
INTEGRATED BRACHYTHERAPY UNIT - DIGITAL (K072445)Nucletron Corp.2007-09-14
IKOENGELO (K061006)Ikoetech, LLC2006-06-05
SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM (K052361)Nucletron Corporation2005-10-24
ADVANTAGE SIM MD (K052345)GE Healthcare2005-09-14
SIMULIX EVOLUTION (K033470)Nucletron Corporation2004-02-04
ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY (K033339)Varian Medical Systems, Inc.2003-12-30
EXOMIO, MODEL 2.0 SP1 (K032550)Medcom GmbH2003-09-25
ACUITY RADIATION THERAPY SIMULATOR (K023052)Varian Medical Systems, Inc.2002-10-11
EXOMIO, MODEL 1.1 (K022219)Medcom GmbH2002-10-07
ADVANTAGE SIM 6.0 (K021780)General Electric Medical Systems2002-07-29
QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00 (K013531)Impac Medical Systems, Inc.2001-11-07
SOMAVISION (K992751)Varian Assoc., Inc.2000-02-16
HELAX-IMCON, VERSION 1.0 (K982857)Helax AB1998-11-04
IBU, INTEGRATED BRACHY THERAPY UNIT (K973848)Nucletron Corp.1998-01-22
VARIAN RADIATION THERAPY IMAGING SYSTEM (K971839)Varian Medical Systems, Inc.1997-08-15
SHADOWFORM (K964972)I.Z.I. Medical Products Corp.1997-05-05
VARIAN XIMATRON C-SERIES RADIATION THERAPY SIMULATOR WITH VERSION 4.2 SOFTWARE (K964138)Varian Medical Systems, Inc.1997-01-10
SIMVIEW 3000 CT OPTION (K953233)Siemens Medical Solutions USA, Inc.1996-11-29
MODEL 555 010 XY CONVERSION(55010) (K960737)Systems Supply Services, Inc.1996-05-22
ADVANTAGE SIM (K951830)General Electric Co.1995-11-13
CTPORT CT SIMULATION SYSTEM FOR RADIOTHERAPY (K945838)Toshiba America Medical Systems, In.C1995-10-25
SIMULIX-HP (K946128)Oldelft Corp. of America1995-05-12
SIMVIEW(TM) 3000 (K946053)Siemens Medical Solutions USA, Inc.1995-03-31
MODEL ASYM-100 (K930213)Nucletron Mfg. Corp.1993-09-07
CMS RECORD AND VERIFY (K921108)Computerized Medical Systems, Inc.1992-11-02
ACQSIM SIMULATOR/LOCALIZER (K923851)Philips Medical Systems (Cleveland), Inc.1992-10-27
E.Z. PORT(TM) RADIATION THERAPY SKIN MARKERS (K922287)I.Z.I. Corp.1992-10-16
CONTOURING DEVICE (K920506)X-Icon Medical Systems1992-10-14
MKS BEAM OUTLINE PROJECTOR (K921876)Medical Knowledge Systems, Inc.1992-06-25
SCANDIPLAN - VERSION 338 (K914926)Scanditronix, Inc.1992-05-28
MODULEX RTP SYSTEM (K913017)Computerized Medical Systems, Inc.1991-10-17
RAHD 3100 (K903313)Esm , Ltd.1991-10-07
XIMATRON/CT OPTION (K910647)Fischer Imaging Corp.1991-09-19
AUTOCOMP (K911340)Victoreen, Inc.1991-08-26
OLDELFT SIMULIX-MC (K912466)Oldelft Corp. of America1991-06-28
COMPUTE-RX-COMP (TM) (K910367)Medicalibration Physics Consultant Services, Inc.1991-05-30
CTS COMPUTED TOMOGRAPHY (CT) ATTACHMENT (K896555)W. L. Systems, Inc.1990-04-26
NEW RAD-8 TREATMENT PLANNING COMPUTER SYSTEM (K894568)Advanced Medical Systems, Inc.1990-01-09
GE TARGET SERIES 2 (K896353)GE Medical Systems1989-12-22
THE X-RAY DIGITIZER, ALTEK MODEL ACT20020-BL (K895442)Altek Corp.1989-12-14
PROWESS 2000 (K884261)Small Systems Group, Inc.1989-08-04
SLS SIMULATOR (MODELS SLS-9 AND SLS-14) (K891293)Philips Medical Systems North America, Inc.1989-04-20
XIMAVIEW(TM) (K884323)Varian Assoc., Inc.1989-04-03
SIMRITE VERIFICATION AND SIMULATION SYSTEM (K885081)Haynes Radiation Ltd., Inc.1989-03-22
MHTI CT-SIM RADIATION THERAPY TREATMENT SIMULATOR (K873580)Medical High Technology International, Inc.1987-11-02
T.O.P. 2000 (TOMOGRAPHIC ORIENTATED PLANNING) (K870221)Kermath Mfg. Corp.1987-05-12
RADIATION BEAM DATA ACQUISTIOIN SYSTEMS (K854880)Computerized Medical Systems, Inc.1986-01-10
BEAMSCAN (K853671)Victoreen, Inc.1986-01-10
VARIAN XIMATRON C-SERIES RADIOTHERAPY TREATMENT ST (K853349)Varian Assoc., Inc.1985-10-28
MEVAPLAN AND SOMADOS (K852410)Siemens Medical Solutions USA, Inc.1985-10-28
THERPAC-RADIATION THERAPY TREATMENT PLANNING SYSTE (K851813)Victoreen, Inc.1985-08-07
COMPUTE RX-PLAN (K850977)Medicalibration1985-07-26
VARIAN/XIMATRON 5 CARBON-FIBER COUCH TOP (K851653)Varian Assoc., Inc.1985-05-23
RAD II SIMULATOR (K834281)Haynes Radiation Ltd., Inc.1983-12-29
KERMATH THERAPY SIMULATOR (K812726)Kermath Mfg. Corp.1981-11-05
XIMATRON V (K810858)Siemens Corp.1981-05-13
PFIZER PZ-SLM RAD. THERAPY TRTMT. SIMUL. (K803032)Pfizer Medical Systems, Inc.1981-01-22
SIDOS U. (K803124)Siemens Corp.1981-01-22
RADIATION ONCOLOGY SYSTEM (K782005)Adac Laboratories1978-12-20
EMI SIMULATOR REMOTE CONTROL CONSOLE (K781519)Emi Medical, Inc.1978-09-14
XIMATRON IV (K781496)Siemens Elema AB1978-09-14
X-RAY SYSTEM (K780963)General X-Ray, Inc.1978-06-27
CTM (CLINAC TREATMENT MONITOR) (K770202)Varian Assoc., Inc.1977-02-07
VARIPLAN COMPUT. RADIOTHERAPY (K761265)Varian Assoc., Inc.1976-12-21
FILTER, VACUUM LINE LINEGUARD (K760420)Diemolding Corp.1976-08-23

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Every clearance here is in the API, with alerts when new ones post.