FDA Product Code
FDA Product Code IYE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.5050
510(k) Clearances — 738 records · page 4 of 8
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K100691 | OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500 | Bionix Development Corp. | 2010-05-11 | Traditional | PDF ↗ |
| K100096 | LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART | Integra Radionics, Inc. | 2010-04-22 | Traditional | PDF ↗ |
| K100264 | T-FORM EXTREMITY IMMOBILIZER, MODEL RT-6060 | Bionix Development Corp. | 2010-04-09 | Traditional | PDF ↗ |
| K100115 | XVI R4.5 | Elekta , Ltd. | 2010-03-10 | Traditional | PDF ↗ |
| K092424 | P-ART, MODEL 001 | P-Cure, Ltd. | 2010-03-05 | Traditional | PDF ↗ |
| K100267 | FLEXIMARC, MODEL CM-0.9-2-10-GG-L | Cortex Manufacturing, Inc. | 2010-02-24 | Traditional | PDF ↗ |
| K092845 | RESPISENS | Nomics | 2010-01-26 | Traditional | PDF ↗ |
| K092479 | SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL | Dyn'R | 2010-01-11 | Traditional | PDF ↗ |
| K093527 | ARIA RADIATION ONCOLOGY WITH MIRS | Varian Medical Systems, Inc. | 2009-12-15 | Special | PDF ↗ |
| K092550 | TIGRT IVS | Linatech, LLC | 2009-12-15 | Traditional | PDF ↗ |
| K092871 | TRILOGY MX | Varian Medical Systems, Inc. | 2009-11-30 | Traditional | PDF ↗ |
| K092939 | PATLOG 2.0 | Oncolog Medical QA AB | 2009-10-09 | Traditional | PDF ↗ |
| K092041 | STELLAR FIDUCIAL MARKER, MODEL GFMIA | Stellar Medical, LLC | 2009-10-02 | Traditional | PDF ↗ |
| K092145 | 160MLC OPTION | Siemens Medical Solutions USA, Inc. | 2009-09-18 | Traditional | PDF ↗ |
| K091999 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM | Accuray, Inc. | 2009-09-18 | Special | PDF ↗ |
| K092018 | OMNIPRO INCLINE | Iba Dosimetry GmbH | 2009-09-18 | Traditional | PDF ↗ |
| K092019 | MODEL 1014 PC ELECTROMETER | Sun Nuclear Corp. | 2009-09-15 | Traditional | PDF ↗ |
| K092285 | PORTABLE DOSIMETER DOSE VERIFICATION SYSTEM, MODEL TD-RD-90 | Best Medical Canada , Ltd. | 2009-08-28 | Special | PDF ↗ |
| K091645 | GOLD ANCHOR | Naslund Medical AB | 2009-07-21 | Traditional | PDF ↗ |
| K090802 | TIGRT MLC, TIGRT DMLC | Linatech, LLC | 2009-07-07 | Traditional | PDF ↗ |
| K091209 | PORTALVISION ADVANCED IMAGING | Varian Medical Systems, Inc. | 2009-06-23 | Traditional | PDF ↗ |
| K091602 | MUCHECK V8 | Oncology Data Systems, Inc. | 2009-06-18 | Traditional | PDF ↗ |
| K091132 | 4D INTEGRATED TREATMENT CONSOLE | Varian Medical Systems | 2009-06-17 | Special | PDF ↗ |
| K090683 | SYNGO RT THERAPIST CONNECT | Siemens Medical Solutions USA, Inc. | 2009-05-08 | Special | PDF ↗ |
| K082582 | SENTINEL, MODEL SP-001 | C-Rad Positioning AB | 2009-03-30 | Traditional | PDF ↗ |
| K090349 | CLEARVUE PRONE BREAST TREATMENT TABLE | Orbital Therapy, LLC | 2009-03-09 | Traditional | PDF ↗ |
| K082775 | PRESCISION OPTION | Siemens Medical Solutions USA, Inc. | 2009-02-19 | Traditional | PDF ↗ |
| K090044 | PATLOG, PATLOG PATIENT HANDLING SYSTEM, PATLOG TOPLOG TABLE TOP, MODEL(S) 1.0, 1.0, C | Oncolog Medical QA AB | 2009-01-22 | Traditional | PDF ↗ |
| K082909 | RSVP HALF SPHERE PHANTOM, MODEL DDP010 | The Phantom Laboratory, Inc. | 2008-12-23 | Traditional | PDF ↗ |
| K082773 | STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331 | Standard Imaging, Inc. | 2008-11-19 | Traditional | PDF ↗ |
| K081935 | STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100 | Aktina Medical Physics Corp. | 2008-10-07 | Traditional | PDF ↗ |
| K082122 | MLCI2 | Elekta , Ltd. | 2008-08-29 | Special | PDF ↗ |
| K081859 | MODIFICATION TO ONEDOSE PATIENT DOSIMETRY SYSTEM | Sicel Technologies, Inc. | 2008-08-04 | Special | PDF ↗ |
| K081760 | RSVP PHANTOM PELVIS, MODEL TLP260 | The Phantom Laboratory, Inc. | 2008-07-29 | Traditional | PDF ↗ |
| K081218 | BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST | It-V Medizintechnik, GmbH | 2008-07-21 | Traditional | PDF ↗ |
| K081188 | TRILOGY WITH EXTERNAL SYSTEM GATING INTERFACE | Varian Medical Systems, Inc. | 2008-07-14 | Traditional | PDF ↗ |
| K080585 | DESKTOP PRO | Elekta , Ltd. | 2008-06-11 | Traditional | PDF ↗ |
| K080072 | MRI PATIENT POSITIONING DEVICES | CIVCO Medical Instruments Co., Inc. | 2008-06-04 | Traditional | PDF ↗ |
| K080726 | CALYPSO 4D LOCALIZATION SYSTEM | Calypso Medical Technologies, Inc. | 2008-05-14 | Traditional | PDF ↗ |
| K080742 | VERISUITE 1.6, VERISUITE-PARTICLE 1.6 | Medcom GmbH | 2008-05-09 | Traditional | PDF ↗ |
| K081036 | 4D INTEGRATED TREATMENT CONSOLE WITH PATIENT ACCESSORY VERIFICATION SYSTEM (PAVS) | Varian Medical Systems, Inc. | 2008-05-09 | Special | PDF ↗ |
| K073018 | STEREOTACTIC TARGET POSITIONER, TARGET POSITIONER FOR LEKSELL HEADRING, STEREOTACTIC COUNTERWEIGHT | Brainlab AG | 2008-01-23 | Traditional | PDF ↗ |
| K072485 | ARTISTE MV SA | Siemens Medical Solutions USA, Inc. | 2007-12-27 | Traditional | PDF ↗ |
| K073273 | EQUAL DOSE 1.0 | Nucletron Corporation | 2007-12-11 | Traditional | PDF ↗ |
| K072374 | COMPASS | Scanditronix Wellhofer GmbH | 2007-12-07 | Traditional | PDF ↗ |
| K072916 | TRILOGY SYSTEM WITH RAPIDARC | Varian Medical Systems, Inc. | 2007-11-09 | Special | PDF ↗ |
| K072506 | EXACTRAC 5.5 | Brainlab AG | 2007-10-26 | Traditional | PDF ↗ |
| K072529 | TRACKPORT | Direx Systems Corp. | 2007-10-26 | Traditional | PDF ↗ |
| K072046 | EXACTRAC 3RD PARTY, EXACTRAC X-RAY 6D 3RD PARTY, EXACTRAC OEM | Brainlab AG | 2007-10-17 | Traditional | PDF ↗ |
| K072454 | INTEGRA RADIONICS INTERFIX PATIENT ADAPTERS | Integra Radionics, Inc. | 2007-10-16 | Traditional | PDF ↗ |
| K072171 | GATECT-RT | Vision RT Limited | 2007-10-01 | Traditional | PDF ↗ |
| K072504 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM | Accuray Incorporated | 2007-09-21 | Special | PDF ↗ |
| K071614 | FIDUCIAL MARKERS | Civco | 2007-09-11 | Traditional | PDF ↗ |
| K072047 | MHI-TM2000 LINEAR ACCELERATOR SYSTEM | Mitsubishi Heavy Industries, Ltd. | 2007-08-29 | Traditional | PDF ↗ |
| K071531 | MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM | Accuray Incorporated | 2007-08-22 | Traditional | PDF ↗ |
| K071992 | HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC) | Varian Medical Systems | 2007-08-15 | Special | PDF ↗ |
| K072079 | IGUIDE SYSTEM | Medical Intelligence Medizintechnik-GmbH-An Elekta | 2007-08-14 | Traditional | PDF ↗ |
| K071701 | TRACKLEAF-10 | Direx Systems Corp. | 2007-07-23 | Special | PDF ↗ |
| K071673 | ONC SOLUTIONS MARKER, MODELS 001001 TO 001012 AND 001021 TO 001032 | Onc Solutions, Inc. | 2007-07-18 | Traditional | PDF ↗ |
| K070611 | BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM, VERSION 6 | Nomos Corp. | 2007-07-11 | Traditional | PDF ↗ |
| K071360 | OPTICAL GUIDANCE PLATFORM | Varian Medical Systems, Inc. | 2007-06-08 | Special | PDF ↗ |
| K070920 | FUJI IP CASSETTE TYPE PC | Fujifilm Medical Systems U.S.A, Inc. | 2007-05-22 | Traditional | PDF ↗ |
| K070305 | PRE-LOADED VISICOIL | Radiomed Corporation | 2007-03-07 | Special | PDF ↗ |
| K070094 | TRILOGY RADIOTHERAPY DELIVERY SYSTEM AND TRILOGY TX DELIVERY SYSTEM | Varian Medical Systems, Inc. | 2007-02-09 | Special | PDF ↗ |
| K063839 | POSITIONER | C-Rad Positioning AB | 2007-02-08 | Traditional | PDF ↗ |
| K063270 | RPM RESPIRATORY GATING SYSTEM | Varian Medical Systems, Inc. | 2006-12-14 | Traditional | PDF ↗ |
| K063274 | ACCULOC BREAST LOCALIZATION SYSTEM | Northwest Medical Physics Equipment, Inc. | 2006-12-12 | Traditional | PDF ↗ |
| K063021 | PROFILER 2 | Sun Nuclear Corp. | 2006-11-22 | Traditional | PDF ↗ |
| K062817 | PTW DAVID IMRT QC VERIFICATION SYSTEM | Ptw-New York Corp. | 2006-11-22 | Traditional | PDF ↗ |
| K062618 | TRILOGY TX WITH 3RD PARTY COUCH TOP SUPPORT | Varian Medical Systems, Inc. | 2006-09-22 | Special | PDF ↗ |
| K062611 | IGUIDE SYSTEM | Medical Intelligence Medizintechnik-GmbH-An Elekta | 2006-09-20 | Traditional | PDF ↗ |
| K060906 | CALYPSO 4D LOCALIZATION SYSTEM | Calypso Medical Technologies, Inc. | 2006-07-28 | Traditional | PDF ↗ |
| K060895 | NOMOSSTAT, VERSION 1.0 | Nomos Corp. | 2006-07-21 | Special | PDF ↗ |
| K061713 | MAGIS1;MAGIS2 | Direx Systems Corp. | 2006-07-21 | Special | PDF ↗ |
| K061140 | TRILOGY RADIOTHERAPY DELIVERY SYSTEM | Varian Medical Systems | 2006-05-15 | Traditional | PDF ↗ |
| K060633 | COHERENCE ONCOLOGIST WORKSPACE, MODEL 2.0 AND PHYSICIST WORKSPACE, MODEL 1.0 | Siemens Medical Solutions USA, Inc. | 2006-05-01 | Traditional | PDF ↗ |
| K060912 | MODIFICATION TO: HI-ART SYSTEM | Tomotherapy Incorporated | 2006-04-19 | Special | PDF ↗ |
| K060737 | SINMED POSITIONING DEVICES | Sinmed BV | 2006-03-31 | Traditional | PDF ↗ |
| K060226 | ONCOR EXPRESSION | Siemens Medical Solutions USA, Inc. | 2006-03-15 | Traditional | PDF ↗ |
| K052212 | MIGUE | Direx Systems Corp. | 2006-03-10 | Traditional | PDF ↗ |
| K052705 | DART-12 | Direx Systems Corp. | 2006-02-21 | Traditional | PDF ↗ |
| K053500 | FRAMELESS RADIOSURGERY COMPONENTS | Brainlab AG | 2006-02-03 | Traditional | PDF ↗ |
| K052920 | DELTA4 | Scandidos AB | 2006-01-12 | Traditional | PDF ↗ |
| K052682 | ALIGNRT | Vision RT Limited | 2006-01-06 | Traditional | PDF ↗ |
| K052391 | VISION (WITH OFF-LINE REVIEW) | Varian Medical Systems | 2005-11-23 | Special | PDF ↗ |
| K052220 | IPLAN RT FIBERTRACKING | Brainlab AG | 2005-09-30 | Traditional | PDF ↗ |
| K051932 | ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5 | Elekta, Inc. | 2005-08-12 | Special | PDF ↗ |
| K051921 | THE EDGE DETECTOR, MODEL 1118 | Sun Nuclear Corp. | 2005-07-27 | Traditional | PDF ↗ |
| K042875 | NAVIGATOR | Nomos Corp. | 2005-07-01 | Traditional | PDF ↗ |
| K050888 | INTEGRA IMMOBILIZATION SYSTEM | Diacor, Inc. | 2005-05-23 | Traditional | PDF ↗ |
| K043409 | ACCUCHANGER | Direx Systems Corp. | 2005-05-05 | Traditional | PDF ↗ |
| K050701 | THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010 | Bionix Development Corp. | 2005-04-01 | Traditional | PDF ↗ |
| K050372 | VISITRAK, VERSION 1, RELEASE 1 | Math Resolutions, LLC | 2005-03-25 | Traditional | PDF ↗ |
| K050479 | 4D INTEGRATED TREATMENT CONSOLE | Varian Medical Systems | 2005-03-24 | Special | PDF ↗ |
| K050442 | MILLENNIUM MULTI-LEAF COLLIMATOR | Varian Medical Systems | 2005-03-23 | Special | PDF ↗ |
| K042956 | VISION | Varian Medical Systems, Inc. | 2005-03-11 | Traditional | PDF ↗ |
| K042794 | BEAM MODULATOR, MODEL 4513 332 8000 | Elekta , Ltd. | 2005-01-31 | Traditional | PDF ↗ |
| K041937 | RESTITU | Resonant Medical, Inc. | 2004-11-16 | Traditional | PDF ↗ |
| K042720 | ON-BOARD IMAGER DEVICE | Varian Medical Systems | 2004-10-29 | Special | PDF ↗ |
| K041519 | MODIFICATION TO: ON-BOARD IMAGER DEVICE | Varian Medical Systems, Inc. | 2004-08-04 | Special | PDF ↗ |
Product code IYE · Class II · Radiology. Data: openFDA.