Accelerator, Linear, Medical
Regulation 892.5050
15510(k)s in 12 months (738 all time)
8recalls in 12 months (563 all time)
542recalls that name a 510(k)
Top companies in IYE
| Company | 510(k)s | Recalls |
|---|---|---|
| Siemens Medical Solutions USA, Inc. | 18 | 206 |
| Varian Medical Systems | 83 | 27 |
| Elekta , Ltd. | 19 | 77 |
| Varian Medical Systems, Oncology Systems | 2 | 68 |
| Accuray Incorporated | 19 | 32 |
| Landauer | 1 | 39 |
| Brainlab | 22 | 17 |
| Varian Assoc., Inc. | 27 | 0 |
| Medtec, Inc. | 20 | 0 |
| Sun Nuclear Corp. | 19 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 1, 2007 | K072171 | GATECT-RT Vision RT Limited | IYE |
| Sep 21, 2007 | K072504 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM Accuray Incorporated | IYE |
| Sep 11, 2007 | K071614 | FIDUCIAL MARKERS Civco | IYE |
| Aug 29, 2007 | K072047 | MHI-TM2000 LINEAR ACCELERATOR SYSTEM Mitsubishi Heavy Industries, Ltd., JP | IYE |
| Aug 22, 2007 | K071531 | MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM Accuray Incorporated | IYE |
| Aug 15, 2007 | K071992 | HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC) Varian Medical Systems | IYE |
| Aug 14, 2007 | K072079 | IGUIDE SYSTEM Medical Intelligence Medizintechnik-GmbH-An Elekta, DE | IYE |
| Jul 23, 2007 | K071701 | TRACKLEAF-10 Direx Systems Corp. | IYE |
| Jul 18, 2007 | K071673 | ONC SOLUTIONS MARKER, MODELS 001001 TO 001012 AND 001021 TO 001032 Onc Solutions, Inc. | IYE |
| Jul 11, 2007 | K070611 | BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM, VERSION 6 Nomos Corp. | IYE |
| Jun 8, 2007 | K071360 | OPTICAL GUIDANCE PLATFORM Varian Medical Systems, Inc. | IYE |
| May 22, 2007 | K070920 | FUJI IP CASSETTE TYPE PC Fujifilm Medical Systems U.S.A, Inc. | IYE |
| Mar 7, 2007 | K070305 | PRE-LOADED VISICOIL Radiomed Corporation | IYE |
| Feb 9, 2007 | K070094 | TRILOGY RADIOTHERAPY DELIVERY SYSTEM AND TRILOGY TX DELIVERY SYSTEM Varian Medical Systems, Inc. | IYE |
| Feb 8, 2007 | K063839 | POSITIONER C-Rad Positioning AB, SE | IYE |
| Dec 14, 2006 | K063270 | RPM RESPIRATORY GATING SYSTEM Varian Medical Systems, Inc. | IYE |
| Dec 12, 2006 | K063274 | ACCULOC BREAST LOCALIZATION SYSTEM Northwest Medical Physics Equipment, Inc. | IYE |
| Nov 22, 2006 | K063021 | PROFILER 2 Sun Nuclear Corp. | IYE |
| Nov 22, 2006 | K062817 | PTW DAVID IMRT QC VERIFICATION SYSTEM Ptw-New York Corp. | IYE |
| Sep 22, 2006 | K062618 | TRILOGY TX WITH 3RD PARTY COUCH TOP SUPPORT Varian Medical Systems, Inc. | IYE |
| Sep 20, 2006 | K062611 | IGUIDE SYSTEM Medical Intelligence Medizintechnik-GmbH-An Elekta, DE | IYE |
| Jul 28, 2006 | K060906 | CALYPSO 4D LOCALIZATION SYSTEM Calypso Medical Technologies, Inc. | IYE |
| Jul 21, 2006 | K061713 | MAGIS1;MAGIS2 Direx Systems Corp. | IYE |
| Jul 21, 2006 | K060895 | NOMOSSTAT, VERSION 1.0 Nomos Corp. | IYE |
| May 15, 2006 | K061140 | TRILOGY RADIOTHERAPY DELIVERY SYSTEM Varian Medical Systems | IYE |
| May 1, 2006 | K060633 | COHERENCE ONCOLOGIST WORKSPACE, MODEL 2.0 AND PHYSICIST WORKSPACE, MODEL 1.0 Siemens Medical Solutions USA, Inc. | IYE |
| Apr 19, 2006 | K060912 | MODIFICATION TO: HI-ART SYSTEM Tomotherapy Incorporated | IYE |
| Mar 31, 2006 | K060737 | SINMED POSITIONING DEVICES Sinmed BV, NL | IYE |
| Mar 15, 2006 | K060226 | ONCOR EXPRESSION Siemens Medical Solutions USA, Inc. | IYE |
| Mar 10, 2006 | K052212 | MIGUE Direx Systems Corp. | IYE |
| Feb 21, 2006 | K052705 | DART-12 Direx Systems Corp. | IYE |
| Feb 3, 2006 | K053500 | FRAMELESS RADIOSURGERY COMPONENTS Brainlab AG, DE | IYE |
| Jan 12, 2006 | K052920 | DELTA4 Scandidos AB, SE | IYE |
| Jan 6, 2006 | K052682 | ALIGNRT Vision RT Limited, GB | IYE |
| Nov 23, 2005 | K052391 | VISION (WITH OFF-LINE REVIEW) Varian Medical Systems | IYE |
| Sep 30, 2005 | K052220 | IPLAN RT FIBERTRACKING Brainlab AG, DE | IYE |
| Aug 12, 2005 | K051932 | ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5 Elekta, Inc. | IYE |
| Jul 27, 2005 | K051921 | THE EDGE DETECTOR, MODEL 1118 Sun Nuclear Corp. | IYE |
| Jul 1, 2005 | K042875 | NAVIGATOR Nomos Corp. | IYE |
| May 23, 2005 | K050888 | INTEGRA IMMOBILIZATION SYSTEM Diacor, Inc. | IYE |
| May 5, 2005 | K043409 | ACCUCHANGER Direx Systems Corp. | IYE |
| Apr 1, 2005 | K050701 | THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010 Bionix Development Corp. | IYE |
| Mar 25, 2005 | K050372 | VISITRAK, VERSION 1, RELEASE 1 Math Resolutions, LLC | IYE |
| Mar 24, 2005 | K050479 | 4D INTEGRATED TREATMENT CONSOLE Varian Medical Systems | IYE |
| Mar 23, 2005 | K050442 | MILLENNIUM MULTI-LEAF COLLIMATOR Varian Medical Systems | IYE |
| Mar 11, 2005 | K042956 | VISION Varian Medical Systems, Inc. | IYE |
| Jan 31, 2005 | K042794 | BEAM MODULATOR, MODEL 4513 332 8000 Elekta , Ltd. | IYE |
| Nov 16, 2004 | K041937 | RESTITU Resonant Medical, Inc. | IYE |
| Oct 29, 2004 | K042720 | ON-BOARD IMAGER DEVICE Varian Medical Systems | IYE |
| Aug 4, 2004 | K041519 | MODIFICATION TO: ON-BOARD IMAGER DEVICE Varian Medical Systems, Inc. | IYE |
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