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 |
|---|---|---|---|
| May 11, 2010 | K100691 | OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500 Bionix Development Corp. | IYE |
| Apr 22, 2010 | K100096 | LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART Integra Radionics, Inc. | IYE |
| Apr 9, 2010 | K100264 | T-FORM EXTREMITY IMMOBILIZER, MODEL RT-6060 Bionix Development Corp. | IYE |
| Mar 10, 2010 | K100115 | XVI R4.5 Elekta , Ltd., GB | IYE |
| Mar 5, 2010 | K092424 | P-ART, MODEL 001 P-Cure, Ltd., IL | IYE |
| Feb 24, 2010 | K100267 | FLEXIMARC, MODEL CM-0.9-2-10-GG-L Cortex Manufacturing, Inc. | IYE |
| Jan 26, 2010 | K092845 | RESPISENS Nomics, BE | IYE |
| Jan 11, 2010 | K092479 | SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL Dyn'R, FR | IYE |
| Dec 15, 2009 | K093527 | ARIA RADIATION ONCOLOGY WITH MIRS Varian Medical Systems, Inc. | IYE |
| Dec 15, 2009 | K092550 | TIGRT IVS Linatech, LLC | IYE |
| Nov 30, 2009 | K092871 | TRILOGY MX Varian Medical Systems, Inc. | IYE |
| Oct 9, 2009 | K092939 | PATLOG 2.0 Oncolog Medical QA AB, SE | IYE |
| Oct 2, 2009 | K092041 | STELLAR FIDUCIAL MARKER, MODEL GFMIA Stellar Medical, LLC | IYE |
| Sep 18, 2009 | K092145 | 160MLC OPTION Siemens Medical Solutions USA, Inc. | IYE |
| Sep 18, 2009 | K092018 | OMNIPRO INCLINE Iba Dosimetry GmbH | IYE |
| Sep 18, 2009 | K091999 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM Accuray, Inc. | IYE |
| Sep 15, 2009 | K092019 | MODEL 1014 PC ELECTROMETER Sun Nuclear Corp. | IYE |
| Aug 28, 2009 | K092285 | PORTABLE DOSIMETER DOSE VERIFICATION SYSTEM, MODEL TD-RD-90 Best Medical Canada , Ltd., CA | IYE |
| Jul 21, 2009 | K091645 | GOLD ANCHOR Naslund Medical AB, SE | IYE |
| Jul 7, 2009 | K090802 | TIGRT MLC, TIGRT DMLC Linatech, LLC | IYE |
| Jun 23, 2009 | K091209 | PORTALVISION ADVANCED IMAGING Varian Medical Systems, Inc. | IYE |
| Jun 18, 2009 | K091602 | MUCHECK V8 Oncology Data Systems, Inc. | IYE |
| Jun 17, 2009 | K091132 | 4D INTEGRATED TREATMENT CONSOLE Varian Medical Systems | IYE |
| May 8, 2009 | K090683 | SYNGO RT THERAPIST CONNECT Siemens Medical Solutions USA, Inc. | IYE |
| Mar 30, 2009 | K082582 | SENTINEL, MODEL SP-001 C-Rad Positioning AB, SE | IYE |
| Mar 9, 2009 | K090349 | CLEARVUE PRONE BREAST TREATMENT TABLE Orbital Therapy, LLC | IYE |
| Feb 19, 2009 | K082775 | PRESCISION OPTION Siemens Medical Solutions USA, Inc. | IYE |
| Jan 22, 2009 | K090044 | PATLOG, PATLOG PATIENT HANDLING SYSTEM, PATLOG TOPLOG TABLE TOP, MODEL(S) 1.0, 1.0, C Oncolog Medical QA AB, SE | IYE |
| Dec 23, 2008 | K082909 | RSVP HALF SPHERE PHANTOM, MODEL DDP010 The Phantom Laboratory, Inc. | IYE |
| Nov 19, 2008 | K082773 | STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331 Standard Imaging, Inc. | IYE |
| Oct 7, 2008 | K081935 | STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100 Aktina Medical Physics Corp. | IYE |
| Aug 29, 2008 | K082122 | MLCI2 Elekta , Ltd., GB | IYE |
| Aug 4, 2008 | K081859 | MODIFICATION TO ONEDOSE PATIENT DOSIMETRY SYSTEM Sicel Technologies, Inc. | IYE |
| Jul 29, 2008 | K081760 | RSVP PHANTOM PELVIS, MODEL TLP260 The Phantom Laboratory, Inc. | IYE |
| Jul 21, 2008 | K081218 | BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST It-V Medizintechnik, GmbH | IYE |
| Jul 14, 2008 | K081188 | TRILOGY WITH EXTERNAL SYSTEM GATING INTERFACE Varian Medical Systems, Inc. | IYE |
| Jun 11, 2008 | K080585 | DESKTOP PRO Elekta , Ltd., GB | IYE |
| Jun 4, 2008 | K080072 | MRI PATIENT POSITIONING DEVICES CIVCO Medical Instruments Co., Inc. | IYE |
| May 14, 2008 | K080726 | CALYPSO 4D LOCALIZATION SYSTEM Calypso Medical Technologies, Inc. | IYE |
| May 9, 2008 | K081036 | 4D INTEGRATED TREATMENT CONSOLE WITH PATIENT ACCESSORY VERIFICATION SYSTEM (PAVS) Varian Medical Systems, Inc. | IYE |
| May 9, 2008 | K080742 | VERISUITE 1.6, VERISUITE-PARTICLE 1.6 Medcom GmbH, DE | IYE |
| Jan 23, 2008 | K073018 | STEREOTACTIC TARGET POSITIONER, TARGET POSITIONER FOR LEKSELL HEADRING, STEREOTACTIC COUNTERWEIGHT Brainlab AG, DE | IYE |
| Dec 27, 2007 | K072485 | ARTISTE MV SA Siemens Medical Solutions USA, Inc. | IYE |
| Dec 11, 2007 | K073273 | EQUAL DOSE 1.0 Nucletron Corporation | IYE |
| Dec 7, 2007 | K072374 | COMPASS Scanditronix Wellhofer GmbH, DE | IYE |
| Nov 9, 2007 | K072916 | TRILOGY SYSTEM WITH RAPIDARC Varian Medical Systems, Inc. | IYE |
| Oct 26, 2007 | K072529 | TRACKPORT Direx Systems Corp. | IYE |
| Oct 26, 2007 | K072506 | EXACTRAC 5.5 Brainlab AG, DE | IYE |
| Oct 17, 2007 | K072046 | EXACTRAC 3RD PARTY, EXACTRAC X-RAY 6D 3RD PARTY, EXACTRAC OEM Brainlab AG, DE | IYE |
| Oct 16, 2007 | K072454 | INTEGRA RADIONICS INTERFIX PATIENT ADAPTERS Integra Radionics, Inc. | IYE |
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