FDA Product Code
FDA Product Code KPQ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.5840
510(k) Clearances — 70 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K132944 | ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION | Ge Hungary Kft | 2014-03-14 | Traditional | PDF ↗ |
| K132045 | ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS | Ge Hungary Kft | 2013-09-04 | Traditional | PDF ↗ |
| K101038 | RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER | Acceletronics Digital Imaging, LLC | 2010-08-17 | Traditional | PDF ↗ |
| K090706 | ONCENTRA SIMULATION 2.3 | Nucletron Corporation | 2009-06-15 | Traditional | PDF ↗ |
| K083591 | IKOENGELO, VERSION 2 | Ikoetech, LLC | 2008-12-29 | Special | PDF ↗ |
| K072445 | INTEGRATED BRACHYTHERAPY UNIT - DIGITAL | Nucletron Corp. | 2007-09-14 | Special | PDF ↗ |
| K061006 | IKOENGELO | Ikoetech, LLC | 2006-06-05 | Traditional | PDF ↗ |
| K052361 | SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM | Nucletron Corporation | 2005-10-24 | Special | PDF ↗ |
| K052345 | ADVANTAGE SIM MD | GE Healthcare | 2005-09-14 | Traditional | PDF ↗ |
| K033470 | SIMULIX EVOLUTION | Nucletron Corporation | 2004-02-04 | Special | PDF ↗ |
| K033339 | ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY | Varian Medical Systems, Inc. | 2003-12-30 | Traditional | PDF ↗ |
| K032550 | EXOMIO, MODEL 2.0 SP1 | Medcom GmbH | 2003-09-25 | Special | PDF ↗ |
| K023052 | ACUITY RADIATION THERAPY SIMULATOR | Varian Medical Systems, Inc. | 2002-10-11 | Special | PDF ↗ |
| K022219 | EXOMIO, MODEL 1.1 | Medcom GmbH | 2002-10-07 | Traditional | PDF ↗ |
| K021780 | ADVANTAGE SIM 6.0 | General Electric Medical Systems | 2002-07-29 | Traditional | PDF ↗ |
| K013531 | QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00 | Impac Medical Systems, Inc. | 2001-11-07 | Traditional | PDF ↗ |
| K992751 | SOMAVISION | Varian Assoc., Inc. | 2000-02-16 | Traditional | PDF ↗ |
| K982857 | HELAX-IMCON, VERSION 1.0 | Helax AB | 1998-11-04 | Traditional | PDF ↗ |
| K973848 | IBU, INTEGRATED BRACHY THERAPY UNIT | Nucletron Corp. | 1998-01-22 | Traditional | PDF ↗ |
| K971839 | VARIAN RADIATION THERAPY IMAGING SYSTEM | Varian Medical Systems, Inc. | 1997-08-15 | Traditional | PDF ↗ |
| K964972 | SHADOWFORM | I.Z.I. Medical Products Corp. | 1997-05-05 | Traditional | PDF ↗ |
| K964138 | VARIAN XIMATRON C-SERIES RADIATION THERAPY SIMULATOR WITH VERSION 4.2 SOFTWARE | Varian Medical Systems, Inc. | 1997-01-10 | Traditional | PDF ↗ |
| K953233 | SIMVIEW 3000 CT OPTION | Siemens Medical Solutions USA, Inc. | 1996-11-29 | Traditional | PDF ↗ |
| K960737 | MODEL 555 010 XY CONVERSION(55010) | Systems Supply Services, Inc. | 1996-05-22 | Traditional | PDF ↗ |
| K951830 | ADVANTAGE SIM | General Electric Co. | 1995-11-13 | Traditional | PDF ↗ |
| K945838 | CTPORT CT SIMULATION SYSTEM FOR RADIOTHERAPY | Toshiba America Medical Systems, In.C | 1995-10-25 | Traditional | PDF ↗ |
| K946128 | SIMULIX-HP | Oldelft Corp. of America | 1995-05-12 | Traditional | PDF ↗ |
| K946053 | SIMVIEW(TM) 3000 | Siemens Medical Solutions USA, Inc. | 1995-03-31 | Traditional | PDF ↗ |
| K930213 | MODEL ASYM-100 | Nucletron Mfg. Corp. | 1993-09-07 | Traditional | PDF ↗ |
| K921108 | CMS RECORD AND VERIFY | Computerized Medical Systems, Inc. | 1992-11-02 | Traditional | PDF ↗ |
| K923851 | ACQSIM SIMULATOR/LOCALIZER | Philips Medical Systems (Cleveland), Inc. | 1992-10-27 | Traditional | PDF ↗ |
| K922287 | E.Z. PORT(TM) RADIATION THERAPY SKIN MARKERS | I.Z.I. Corp. | 1992-10-16 | Traditional | PDF ↗ |
| K920506 | CONTOURING DEVICE | X-Icon Medical Systems | 1992-10-14 | Traditional | PDF ↗ |
| K921876 | MKS BEAM OUTLINE PROJECTOR | Medical Knowledge Systems, Inc. | 1992-06-25 | Traditional | PDF ↗ |
| K914926 | SCANDIPLAN - VERSION 338 | Scanditronix, Inc. | 1992-05-28 | Traditional | PDF ↗ |
| K913017 | MODULEX RTP SYSTEM | Computerized Medical Systems, Inc. | 1991-10-17 | Traditional | PDF ↗ |
| K903313 | RAHD 3100 | Esm , Ltd. | 1991-10-07 | Traditional | PDF ↗ |
| K910647 | XIMATRON/CT OPTION | Fischer Imaging Corp. | 1991-09-19 | Traditional | PDF ↗ |
| K911340 | AUTOCOMP | Victoreen, Inc. | 1991-08-26 | Traditional | PDF ↗ |
| K912466 | OLDELFT SIMULIX-MC | Oldelft Corp. of America | 1991-06-28 | Traditional | PDF ↗ |
| K910367 | COMPUTE-RX-COMP (TM) | Medicalibration Physics Consultant Services, Inc. | 1991-05-30 | Traditional | PDF ↗ |
| K896555 | CTS COMPUTED TOMOGRAPHY (CT) ATTACHMENT | W. L. Systems, Inc. | 1990-04-26 | Traditional | PDF ↗ |
| K894568 | NEW RAD-8 TREATMENT PLANNING COMPUTER SYSTEM | Advanced Medical Systems, Inc. | 1990-01-09 | Traditional | PDF ↗ |
| K896353 | GE TARGET SERIES 2 | GE Medical Systems | 1989-12-22 | Traditional | PDF ↗ |
| K895442 | THE X-RAY DIGITIZER, ALTEK MODEL ACT20020-BL | Altek Corp. | 1989-12-14 | Traditional | PDF ↗ |
| K884261 | PROWESS 2000 | Small Systems Group, Inc. | 1989-08-04 | Traditional | PDF ↗ |
| K891293 | SLS SIMULATOR (MODELS SLS-9 AND SLS-14) | Philips Medical Systems North America, Inc. | 1989-04-20 | Traditional | PDF ↗ |
| K884323 | XIMAVIEW(TM) | Varian Assoc., Inc. | 1989-04-03 | Traditional | PDF ↗ |
| K885081 | SIMRITE VERIFICATION AND SIMULATION SYSTEM | Haynes Radiation Ltd., Inc. | 1989-03-22 | Traditional | PDF ↗ |
| K873580 | MHTI CT-SIM RADIATION THERAPY TREATMENT SIMULATOR | Medical High Technology International, Inc. | 1987-11-02 | Traditional | PDF ↗ |
| K870221 | T.O.P. 2000 (TOMOGRAPHIC ORIENTATED PLANNING) | Kermath Mfg. Corp. | 1987-05-12 | Traditional | PDF ↗ |
| K853671 | BEAMSCAN | Victoreen, Inc. | 1986-01-10 | Traditional | PDF ↗ |
| K854880 | RADIATION BEAM DATA ACQUISTIOIN SYSTEMS | Computerized Medical Systems, Inc. | 1986-01-10 | Traditional | PDF ↗ |
| K853349 | VARIAN XIMATRON C-SERIES RADIOTHERAPY TREATMENT ST | Varian Assoc., Inc. | 1985-10-28 | Traditional | PDF ↗ |
| K852410 | MEVAPLAN AND SOMADOS | Siemens Medical Solutions USA, Inc. | 1985-10-28 | Traditional | PDF ↗ |
| K851813 | THERPAC-RADIATION THERAPY TREATMENT PLANNING SYSTE | Victoreen, Inc. | 1985-08-07 | Traditional | PDF ↗ |
| K850977 | COMPUTE RX-PLAN | Medicalibration | 1985-07-26 | Traditional | PDF ↗ |
| K851653 | VARIAN/XIMATRON 5 CARBON-FIBER COUCH TOP | Varian Assoc., Inc. | 1985-05-23 | Traditional | PDF ↗ |
| K834281 | RAD II SIMULATOR | Haynes Radiation Ltd., Inc. | 1983-12-29 | Traditional | PDF ↗ |
| K812726 | KERMATH THERAPY SIMULATOR | Kermath Mfg. Corp. | 1981-11-05 | Traditional | PDF ↗ |
| K810858 | XIMATRON V | Siemens Corp. | 1981-05-13 | Traditional | PDF ↗ |
| K803124 | SIDOS U. | Siemens Corp. | 1981-01-22 | Traditional | PDF ↗ |
| K803032 | PFIZER PZ-SLM RAD. THERAPY TRTMT. SIMUL. | Pfizer Medical Systems, Inc. | 1981-01-22 | Traditional | PDF ↗ |
| K782005 | RADIATION ONCOLOGY SYSTEM | Adac Laboratories | 1978-12-20 | Traditional | PDF ↗ |
| K781519 | EMI SIMULATOR REMOTE CONTROL CONSOLE | Emi Medical, Inc. | 1978-09-14 | Traditional | PDF ↗ |
| K781496 | XIMATRON IV | Siemens Elema AB | 1978-09-14 | Traditional | PDF ↗ |
| K780963 | X-RAY SYSTEM | General X-Ray, Inc. | 1978-06-27 | Traditional | PDF ↗ |
| K770202 | CTM (CLINAC TREATMENT MONITOR) | Varian Assoc., Inc. | 1977-02-07 | Traditional | PDF ↗ |
| K761265 | VARIPLAN COMPUT. RADIOTHERAPY | Varian Assoc., Inc. | 1976-12-21 | Traditional | PDF ↗ |
| K760420 | FILTER, VACUUM LINE LINEGUARD | Diemolding Corp. | 1976-08-23 | Traditional | PDF ↗ |
Product code KPQ · Class II · Radiology. Data: openFDA.