Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
KPQ — Predicate Candidate Screening
70 FDA 510(k) clearances under this product code; the 50 most recent screened below.
89 daysmedian FDA review time
235 days90th percentile
70clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K132944 | ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION | Ge Hungary Kft | 2014-03-14 | 176 | 0 |
| K132045 | ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNI | Ge Hungary Kft | 2013-09-04 | 64 | 0 |
| K101038 | RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER | Acceletronics Digital Imaging, LLC | 2010-08-17 | 125 | 0 |
| K090706 | ONCENTRA SIMULATION 2.3 | Nucletron Corporation | 2009-06-15 | 90 | 0 |
| K083591 | IKOENGELO, VERSION 2 | Ikoetech, LLC | 2008-12-29 | 25 | 0 |
| K072445 | INTEGRATED BRACHYTHERAPY UNIT - DIGITAL | Nucletron Corp. | 2007-09-14 | 15 | 0 |
| K061006 | IKOENGELO | Ikoetech, LLC | 2006-06-05 | 55 | 0 |
| K052361 | SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM | Nucletron Corporation | 2005-10-24 | 56 | 0 |
| K052345 | ADVANTAGE SIM MD | GE Healthcare | 2005-09-14 | 19 | 3 |
| K033470 | SIMULIX EVOLUTION | Nucletron Corporation | 2004-02-04 | 93 | 0 |
| K033339 | ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY | Varian Medical Systems, Inc. | 2003-12-30 | 74 | 3 |
| K032550 | EXOMIO, MODEL 2.0 SP1 | Medcom GmbH | 2003-09-25 | 38 | 0 |
| K023052 | ACUITY RADIATION THERAPY SIMULATOR | Varian Medical Systems, Inc. | 2002-10-11 | 28 | 1 |
| K022219 | EXOMIO, MODEL 1.1 | Medcom GmbH | 2002-10-07 | 90 | 0 |
| K021780 | ADVANTAGE SIM 6.0 | General Electric Medical Systems | 2002-07-29 | 60 | 1 |
| K013531 | QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00 | Impac Medical Systems, Inc. | 2001-11-07 | 15 | 0 |
| K992751 | SOMAVISION | Varian Assoc., Inc. | 2000-02-16 | 184 | 0 |
| K982857 | HELAX-IMCON, VERSION 1.0 | Helax AB | 1998-11-04 | 83 | 0 |
| K973848 | IBU, INTEGRATED BRACHY THERAPY UNIT | Nucletron Corp. | 1998-01-22 | 106 | 0 |
| K971839 | VARIAN RADIATION THERAPY IMAGING SYSTEM | Varian Medical Systems, Inc. | 1997-08-15 | 88 | 0 |
| K964972 | SHADOWFORM | I.Z.I. Medical Products Corp. | 1997-05-05 | 144 | 0 |
| K964138 | VARIAN XIMATRON C-SERIES RADIATION THERAPY SIMULATOR WITH VE | Varian Medical Systems, Inc. | 1997-01-10 | 87 | 1 |
| K953233 | SIMVIEW 3000 CT OPTION | Siemens Medical Solutions USA, Inc. | 1996-11-29 | 508 | 4 |
| K960737 | MODEL 555 010 XY CONVERSION(55010) | Systems Supply Services, Inc. | 1996-05-22 | 89 | 0 |
| K951830 | ADVANTAGE SIM | General Electric Co. | 1995-11-13 | 207 | 1 |
| K945838 | CTPORT CT SIMULATION SYSTEM FOR RADIOTHERAPY | Toshiba America Medical Systems, In.C | 1995-10-25 | 330 | 0 |
| K946128 | SIMULIX-HP | Oldelft Corp. of America | 1995-05-12 | 148 | 0 |
| K946053 | SIMVIEW(TM) 3000 | Siemens Medical Solutions USA, Inc. | 1995-03-31 | 109 | 5 |
| K930213 | MODEL ASYM-100 | Nucletron Mfg. Corp. | 1993-09-07 | 235 | 0 |
| K921108 | CMS RECORD AND VERIFY | Computerized Medical Systems, Inc. | 1992-11-02 | 238 | 0 |
| K923851 | ACQSIM SIMULATOR/LOCALIZER | Philips Medical Systems (Cleveland), Inc. | 1992-10-27 | 88 | 0 |
| K922287 | E.Z. PORT(TM) RADIATION THERAPY SKIN MARKERS | I.Z.I. Corp. | 1992-10-16 | 154 | 0 |
| K920506 | CONTOURING DEVICE | X-Icon Medical Systems | 1992-10-14 | 252 | 0 |
| K921876 | MKS BEAM OUTLINE PROJECTOR | Medical Knowledge Systems, Inc. | 1992-06-25 | 66 | 0 |
| K914926 | SCANDIPLAN - VERSION 338 | Scanditronix, Inc. | 1992-05-28 | 206 | 0 |
| K913017 | MODULEX RTP SYSTEM | Computerized Medical Systems, Inc. | 1991-10-17 | 100 | 0 |
| K903313 | RAHD 3100 | Esm , Ltd. | 1991-10-07 | 440 | 0 |
| K910647 | XIMATRON/CT OPTION | Fischer Imaging Corp. | 1991-09-19 | 218 | 0 |
| K911340 | AUTOCOMP | Victoreen, Inc. | 1991-08-26 | 153 | 0 |
| K912466 | OLDELFT SIMULIX-MC | Oldelft Corp. of America | 1991-06-28 | 24 | 0 |
| K910367 | COMPUTE-RX-COMP (TM) | Medicalibration Physics Consultant Services, Inc. | 1991-05-30 | 121 | 0 |
| K896555 | CTS COMPUTED TOMOGRAPHY (CT) ATTACHMENT | W. L. Systems, Inc. | 1990-04-26 | 160 | 0 |
| K894568 | NEW RAD-8 TREATMENT PLANNING COMPUTER SYSTEM | Advanced Medical Systems, Inc. | 1990-01-09 | 172 | 0 |
| K896353 | GE TARGET SERIES 2 | GE Medical Systems | 1989-12-22 | 46 | 0 |
| K895442 | THE X-RAY DIGITIZER, ALTEK MODEL ACT20020-BL | Altek Corp. | 1989-12-14 | 97 | 0 |
| K884261 | PROWESS 2000 | Small Systems Group, Inc. | 1989-08-04 | 297 | 0 |
| K891293 | SLS SIMULATOR (MODELS SLS-9 AND SLS-14) | Philips Medical Systems North America, Inc. | 1989-04-20 | 41 | 0 |
| K884323 | XIMAVIEW(TM) | Varian Assoc., Inc. | 1989-04-03 | 171 | 0 |
| K885081 | SIMRITE VERIFICATION AND SIMULATION SYSTEM | Haynes Radiation Ltd., Inc. | 1989-03-22 | 103 | 0 |
| K873580 | MHTI CT-SIM RADIATION THERAPY TREATMENT SIMULATOR | Medical High Technology International, Inc. | 1987-11-02 | 67 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda