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 |
|---|---|---|---|
| Jun 25, 2004 | K041557 | MOBILEMOSFET WIRELESS DOSIMETRY SYSTEM, MODEL TN-RD-70-W Thomson & Nielsen Electronics, Ltd., CA | IYE |
| Jun 25, 2004 | K040687 | ONEDOSE PATIENT DOSIMETRY SYSTEM Sicel Technologies, Inc. | IYE |
| Jun 10, 2004 | K041315 | CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY Accuray, Inc. | IYE |
| May 11, 2004 | K040585 | EXACTRAC 4.0 AND EXACTRAC X-RAY 6D Brainlab AG, DE | IYE |
| Apr 28, 2004 | K040709 | PROTOS SOFTWARE Aktina Medical Physics Corp. | IYE |
| Apr 9, 2004 | K040773 | PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM Bionix Development Corp. | IYE |
| Apr 5, 2004 | K034051 | DYNATRAC, COD. 50-1A 3D Line USA, Inc. | IYE |
| Feb 27, 2004 | K040192 | ON-BOARD IMAGER DEVICE Varian Medical Systems, Inc. | IYE |
| Dec 23, 2003 | K033343 | TRILOGY RADIOTHERAPY DELIVERY SYSTEM Varian Medical Systems, Inc. | IYE |
| Dec 19, 2003 | K033287 | EXACTRAC GATING Brainlab AG, DE | IYE |
| Dec 15, 2003 | K032171 | ACCUSOFT Direx Systems Corp. | IYE |
| Dec 2, 2003 | K032762 | XIO RADIATION TREATMENT PLANNING SYSTEM Computerized Medical Systems, Inc. | IYE |
| Nov 12, 2003 | K033347 | MODIFICATION TO: HI-ART SYSTEM Tomotherapy Incorporated | IYE |
| Oct 23, 2003 | K032996 | ELEKTA SYNERGY SYSTEM Elekta Oncology Systems, Ltd. | IYE |
| Oct 3, 2003 | K032725 | MOSFET AUTOSENSE WIRELESS Thomson & Nielsen Electronics, Ltd., CA | IYE |
| Oct 2, 2003 | K032100 | I-BEAM Computerized Medical Systems, Inc. | IYE |
| Sep 25, 2003 | K032248 | PRECISE CARBON FIBER TABLE TOP, MODEL 11-999 Aktina Medical Physics Corp. | IYE |
| Sep 5, 2003 | K032594 | ONE DIMENSIONAL WATER PHANTOM, WP 1D Wellhofer Dosimetrie | IYE |
| Sep 5, 2003 | K031764 | ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES Siemens Medical Solutions USA, Inc. | IYE |
| Sep 2, 2003 | K032156 | ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH SHOULDER DEPRESSION, ACCUFIX RADIOLUCENT Wfr/Aquaplast Corp. | IYE |
| Aug 29, 2003 | K031975 | IMSURE Prodigm, Inc. | IYE |
| Aug 29, 2003 | K031634 | OMNIPRO I'MRT Wellhofer Dosimetrie, SE | IYE |
| Jul 18, 2003 | K031631 | STEREOTACTIC BODY FRAME, MODEL COD. 70-1A 3D Line USA, Inc. | IYE |
| May 8, 2003 | K030439 | HEADFIX Medical Intelligence Medizintechnik GmbH | IYE |
| Apr 17, 2003 | K030175 | 2 BASIC Capintec, Inc. | IYE |
| Apr 4, 2003 | K030051 | VERSABOARD, MODEL 7040 Bionix Development Corp. | IYE |
| Mar 11, 2003 | K024284 | VICTOREEN THEBES II, MODEL 7020 Syncor Radiation Management | IYE |
| Jan 16, 2003 | K023519 | RADIONICS VARILINK 2 Radionics, A Division of Tyco Healthcare Group LP | IYE |
| Jan 13, 2003 | K023449 | NON-INVASIVE PATIENT FIXATION SYSTEM Stryker Leibinger | IYE |
| Jan 7, 2003 | K021338 | ACCULEAF Direx Systems Corp. | IYE |
| Dec 23, 2002 | K023293 | MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02 Med-Tec,Inc. | IYE |
| Nov 22, 2002 | K023636 | BLOCKING TRAY Southeastern Radiation Products, Inc. | IYE |
| Nov 12, 2002 | K022708 | KLARITY Larson Products, Inc. | IYE |
| Aug 28, 2002 | K020320 | RADIOSYSTEM/NT, MODEL 80-13020 Styker Instruments | IYE |
| Jul 2, 2002 | K021124 | ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER Wfr/Aquaplast Corp. | IYE |
| Jul 2, 2002 | K010065 | CRANIAL STEREOTACTIC EQUIPMENT Arplay Medical S.A., FR | IYE |
| Jun 6, 2002 | K021463 | MODEL 1133 IVD PC VERSION Sun Nuclear Corp. | IYE |
| Jun 6, 2002 | K020860 | M3 (MICRO-MULTILEAF COLLIMATOR) Brainlab AG, DE | IYE |
| Apr 22, 2002 | K020294 | MOTION TRACKING Accuray, Inc. | IYE |
| Mar 26, 2002 | K004022 | M3 (MIRCO-MULTILEAF COLLIMATOR Brainlab AG, DE | IYE |
| Mar 5, 2002 | K014081 | AKTINA MEDICAL PHYSICS RADIATION THERAPY WEDGES Aktina Medical Physics Corp. | IYE |
| Mar 4, 2002 | K014022 | MRI LINE MARKER I.Z.I. Corp. | IYE |
| Jan 11, 2002 | K013391 | BODYFIX Medical Intelligence Medizintechnik GmbH, DE | IYE |
| Dec 4, 2001 | K011845 | MILLCOMP Math Resolutions, LLC | IYE |
| Oct 18, 2001 | K013279 | MOSFET AUTOSENSE, MODEL TN-RD-60 Thomson & Nielsen Electronics, Ltd., CA | IYE |
| Oct 1, 2001 | K012227 | MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1 Oncology Data Systems, Inc. | IYE |
| Sep 21, 2001 | K004023 | INTRA OPERATIVE RADIATION THERAPY Arplay Medical S.A., FR | IYE |
| Sep 5, 2001 | K011763 | OMNIDOS Scanditronix Medical AB, SE | IYE |
| Aug 14, 2001 | K012289 | MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID) Elekta Oncology Systems, Ltd. | IYE |
| Aug 10, 2001 | K011024 | CYBERKNIFE SYSTEM Accuray, Inc. | IYE |
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