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 3 of 8
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K151207 | Proton Immobilization Solution | Orfit Industries NV | 2015-07-28 | Traditional | PDF ↗ |
| K150873 | CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System | Accuray Incorporated | 2015-07-01 | Traditional | PDF ↗ |
| K150848 | Dose Calculator | Sun Nuclear Corporation | 2015-05-20 | Traditional | PDF ↗ |
| K151097 | Active Breathing Coordinator | Aktina Medical Corporation | 2015-05-15 | Special | PDF ↗ |
| K150706 | VitalBeam | Varian Medical Systems, Inc. | 2015-05-08 | Special | PDF ↗ |
| K142420 | Patient Positioning Devices | Macromedics BV | 2015-03-27 | Traditional | PDF ↗ |
| K142294 | FlexiMarc Marker | Cortex Manufacturing, Inc. | 2015-03-26 | Special | PDF ↗ |
| K143485 | iGuide 2.1 | Medical Intelligence Medizintechnik GmbH | 2015-03-04 | Traditional | PDF ↗ |
| K143224 | TrueBeam-TrueBeam STx-Edge | Varian Medical Systems, Inc. | 2014-12-19 | Special | PDF ↗ |
| K142560 | Varian Head Frame | Varian Medical Systems, Inc. | 2014-12-11 | Traditional | PDF ↗ |
| K142142 | QUALITY REPORTS | Sun Nuclear Corporation | 2014-12-05 | Traditional | PDF ↗ |
| K142431 | WaterProof PROFILER | Sun Nuclear Corporation | 2014-12-05 | Traditional | PDF ↗ |
| K142434 | ARTISTE SOLUTION, SYS_VC10C, PHASE 2 UPDATE WITH THE SYNGO RT THERAPIST & RT ONCOLOGIST WORKSPACES, V4.3.1_MR1 | Siemens Medical Solutions USA, Inc. | 2014-11-21 | Traditional | PDF ↗ |
| K141855 | CLARITY | Elekta , Ltd. | 2014-10-08 | Traditional | PDF ↗ |
| K142268 | Varian Verification System (VVS) | Varian Medical Systems, Inc. | 2014-10-02 | Traditional | PDF ↗ |
| K141800 | PERFRACTION | Sun Nuclear Corporation | 2014-09-26 | Traditional | PDF ↗ |
| K141572 | MOSAIQ ONCOLOGY INFORMATION SYSTEM | Impac Medical Systems, Inc. | 2014-09-05 | Traditional | PDF ↗ |
| K140528 | TRUE BEAM, TRUE BEAM STX, EDGE | Varian Medical Systems, Inc. | 2014-09-05 | Traditional | PDF ↗ |
| K141230 | DOSELAB PRO | Mobius Medical Systems, LP | 2014-08-27 | Traditional | PDF ↗ |
| K141787 | SAGITTILT | Orfit Industries NV | 2014-08-07 | Traditional | PDF ↗ |
| K140823 | PERMANENT BEACON TRANSPONDER/SOFT TISSUE BEACON TRANSPONDER | Varian Medical Systems, Inc. | 2014-06-27 | Traditional | PDF ↗ |
| K140660 | MOBIUS3D | Mobius Medical Systems, LP | 2014-06-24 | Traditional | PDF ↗ |
| K133572 | ARIA RADIATION THERAPY MANAGEMENT | Varian Medical Systems, Inc. | 2014-04-04 | Traditional | PDF ↗ |
| K133227 | SMART SEGMENTATION - KNOWLEDGE BASED CONTOURING | Varian Medical Systems, Inc. | 2014-03-14 | Traditional | PDF ↗ |
| K132908 | TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT ARCH BASE LOCK REPLACEMENT KIT | Medtec, Inc. | 2014-03-04 | Traditional | PDF ↗ |
| K132064 | BIOMARC FIDUCIAL MARKER | Carbon Medical Technologies, Inc. | 2014-02-28 | Traditional | PDF ↗ |
| K132935 | ARTISTE SOLUTION WITH SYS_VC10C AND SYNGO RT THERAPIST WORKSPACE, V4.3.1 UPGRADE KIT, ARIA CONNECTIVITY OPTION FOR SIEME | Siemens Medical Solutions USA, Inc. | 2014-02-21 | Traditional | PDF ↗ |
| K133240 | VARIAN MULTILEAF COLLIMATOR | Varian Medical Systems, Inc. | 2014-01-31 | Traditional | PDF ↗ |
| K132605 | DOSIMETRY CHECK VERSION 4 RELEASE 1 | Math Resolutions, LLC | 2013-11-14 | Traditional | PDF ↗ |
| K132124 | KLARITY VACUUM BAG, KLARITY MOLD CUSHION | Klarity Medical Products, LLC | 2013-11-01 | Traditional | PDF ↗ |
| K132705 | UNIQUE | Varian Medical Systems, Inc. | 2013-10-31 | Traditional | PDF ↗ |
| K131807 | HIGH ENERGY LINEAR ACCELERATOR | Varian Medical Systems, Inc. | 2013-10-11 | Traditional | PDF ↗ |
| K131795 | NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS | Orfit Industries NV | 2013-09-26 | Traditional | PDF ↗ |
| K131965 | XVI R5.0 | Elekta Limited | 2013-09-25 | Traditional | PDF ↗ |
| K131862 | 3DVH | Sun Nuclear Corporation | 2013-08-21 | Traditional | PDF ↗ |
| K131466 | MAPCHECK2, ARCCHECK | Sun Nuclear Corporation | 2013-08-20 | Traditional | PDF ↗ |
| K131313 | ACTIVE BREATHING COORDINATOR | Aktina Medical Corp. | 2013-08-07 | Traditional | PDF ↗ |
| K131704 | EPIDOSE | Sun Nuclear Corporation | 2013-08-05 | Traditional | PDF ↗ |
| K130992 | PINNACLE3 RADIATION THERAPY PLANNING SYSTEM | Philips Medical Systems (Cleveland), Inc. | 2013-06-14 | Traditional | PDF ↗ |
| K121284 | CHABNER XRT GARMENTS | Chabner Xrt, LLC | 2013-06-14 | Traditional | PDF ↗ |
| K122888 | CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEM | Cdr Systems, Inc. | 2013-04-30 | Traditional | PDF ↗ |
| K130678 | BIOMARC GOLD FIDUCIAL MARKER | Carbon Medical Technologies, Inc. | 2013-04-12 | Special | PDF ↗ |
| K123808 | AGILITY | Elekta , Ltd. | 2013-04-04 | Traditional | PDF ↗ |
| K123812 | COHERENCE RT THERAPIST CONNECT WORKSPACE, V2.3, ARIA CONNECTIVITY OPTION FOR SIEMENS NON-IMAGING SYSTEMS, ARIA CONNECTIV | Siemens Medical Solutions USA, Inc. | 2013-03-01 | Traditional | PDF ↗ |
| K123788 | INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI) | Varian Medical Systems, Inc. | 2013-01-15 | Traditional | PDF ↗ |
| K123371 | ALIGNRT PLUS | Vision RT Limited | 2013-01-08 | Traditional | PDF ↗ |
| K122616 | PANTHER OIS/R & V MODEL VERSION 2.0 | Prowess, Inc. | 2012-12-21 | Traditional | PDF ↗ |
| K123291 | TRUEBEAM | Varian Medical Systems, Inc. | 2012-12-20 | Traditional | PDF ↗ |
| K123230 | MOSAIQ ONCOLOGY INFORMATION SYSTEM | Impac Medical Systems, Inc. | 2012-12-12 | Traditional | PDF ↗ |
| K123137 | CALYPSO SYSTEM | Varian Medical Systems | 2012-12-05 | Traditional | PDF ↗ |
| K121663 | CLARITY | Elekta , Ltd. | 2012-12-05 | Traditional | PDF ↗ |
| K122137 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM | Accuray Incorporated | 2012-10-26 | Traditional | PDF ↗ |
| K121657 | PROTON RADIATION THERAPY BEAM-SHAPING APERTURE PROTON RADIAION THERAPY BEAM-SHPING RANGE COMPENSATOR | Proton Systems | 2012-10-23 | Traditional | PDF ↗ |
| K121845 | SDX SYSTEM | Dyn'R Sas | 2012-10-19 | Traditional | PDF ↗ |
| K122450 | MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS | Mitsubishi Heavy Industries, Ltd. | 2012-10-03 | Traditional | PDF ↗ |
| K122451 | EXACTRAC VERO | Brainlab AG | 2012-09-28 | Traditional | PDF ↗ |
| K121934 | TOMOTHERAPY TREATMENT SYSTEM | Accuray Incorporated | 2012-08-29 | Traditional | PDF ↗ |
| K120789 | EXACTRAC X-RAY X-RAY | Brainlab AG | 2012-08-14 | Traditional | PDF ↗ |
| K112692 | IDENTIFY | Humediq GmbH | 2012-08-03 | Traditional | PDF ↗ |
| K120668 | SENTINEL | C-Rad Positioning AB | 2012-07-30 | Traditional | PDF ↗ |
| K121295 | ARTISTETM SOLUTION WITH SYS VCIO | Siemens Medical Solutions USA, Inc. | 2012-06-27 | Traditional | PDF ↗ |
| K121530 | BODYFIX SYSTEM | Medical Intelligence Medizintechnik GmbH | 2012-06-20 | Traditional | PDF ↗ |
| K121328 | AGILITY | Elekta , Ltd. | 2012-06-12 | Traditional | PDF ↗ |
| K111862 | VIEWRAY SYSTEM | Viewray, Incorporated | 2012-05-22 | Traditional | PDF ↗ |
| K120335 | EMBRACE THERMOPLASTIC | Bionix Development Corp. | 2012-05-03 | Traditional | PDF ↗ |
| K112286 | NOVAC 11 | New Radiant Technology S.P.A. | 2012-04-19 | Traditional | PDF ↗ |
| K110840 | LIAC | Sordina S.P.A. | 2012-04-17 | Abbreviated | PDF ↗ |
| K120233 | SYNCHRONY RESPIRATORY TRACKING SYSTEM | Accuray Incorporated | 2012-03-09 | Traditional | PDF ↗ |
| K120067 | MOSAIQ ONCOLOGY INFORMATION SYSTEM | Impac Medical Systems, Inc. | 2012-02-28 | Traditional | PDF ↗ |
| K113276 | CATALYST | C-Rad Positioning AB | 2012-02-27 | Traditional | PDF ↗ |
| K112841 | SURFACE BEACON TRANSPONDERS | Calypso Medical Technologies, Inc. | 2012-02-16 | Traditional | PDF ↗ |
| K111332 | CLARITY OBP SYSTEM | Elekta , Ltd. | 2012-01-30 | Traditional | PDF ↗ |
| K110971 | TRACER IMPLANTATION KIT, INDEX IMPLANTATION KIT | Navotek Medical, Ltd. | 2012-01-10 | Traditional | PDF ↗ |
| K113758 | VOLUSON E6/E8/E8EXPERT/E10 | GE Healthcare | 2012-01-10 | Special | PDF ↗ |
| K112778 | SMART SEGMENTATION-KNOWLEDGE BASED CONTOURING | Varian Medical Systems | 2011-12-29 | Traditional | PDF ↗ |
| K112613 | INTEGRITY(TM) | Elekta Limited | 2011-12-16 | Traditional | PDF ↗ |
| K112210 | FRAXION | Medical Intelligence Medizintechnik GmbH | 2011-11-22 | Traditional | PDF ↗ |
| K112839 | VARIAN HIGH ENERGY LINEAR ACCELERATOR | Varian Medical Systems | 2011-11-14 | Traditional | PDF ↗ |
| K112460 | MULTIPLE | Larson Medical Products, Inc. | 2011-10-07 | Traditional | PDF ↗ |
| K111106 | TRUEBEAM | Varian Medical Systems, Inc. | 2011-08-18 | Traditional | PDF ↗ |
| K110772 | BIOMARC FIDUCIAL MARKER | Carbon Medical Technologies, Inc. | 2011-04-28 | Traditional | PDF ↗ |
| K103606 | ARTISTE SOLUTION WITH SYS_VB50 UPDATE | Siemens Medical Solutions USA, Inc. | 2011-04-15 | Traditional | PDF ↗ |
| K103616 | PINPOINT STEREOTACTIC HEAD AND NECK LOCALIZER | Aktina Medical Physics Corp. | 2011-01-25 | Traditional | PDF ↗ |
| K100625 | REALEYE MODEL VCPS | Navotek Medical, Ltd. | 2011-01-21 | Traditional | PDF ↗ |
| K103394 | BARCODE CONICAL COLLIMATOR VERIFICATION (BCCV) | Varian Medical Systems, Oncology Systems | 2011-01-12 | Traditional | PDF ↗ |
| K103193 | DOSEVIEW 3D | Standard Imaging, Inc. | 2010-12-27 | Traditional | PDF ↗ |
| K102765 | PRONEX | Direx Systems Corp. | 2010-12-07 | Traditional | PDF ↗ |
| K102237 | PVS MODEL 1.0 | Medcom GmbH | 2010-11-23 | Traditional | PDF ↗ |
| K102650 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM | Accuray Incorporated | 2010-11-17 | Traditional | PDF ↗ |
| K102200 | INTEGRITY MODEL 1014284 | Elekta , Ltd. | 2010-11-04 | Traditional | PDF ↗ |
| K102583 | MUCHECK, VERSION 9.0 | Oncology Data Systems, Inc. | 2010-11-02 | Traditional | PDF ↗ |
| K102024 | RPM RESPIRATORY GATING SYSTEM | Varian Medical Systems | 2010-10-15 | Traditional | PDF ↗ |
| K102671 | SYNGO RT THERAPIST CONNECT WORKSPACE, V4.2 | Siemens Medical Solutions USA, Inc. | 2010-10-12 | Traditional | PDF ↗ |
| K101992 | 3D SCANNER, MODEL 1230 | Sun Nuclear Corp. | 2010-10-01 | Traditional | PDF ↗ |
| K101751 | VARIAN UNIQUE SINGLE ENERGY LINEAR ACCELERATOR | Varian Medical Systems, Oncology Systems | 2010-08-10 | Traditional | PDF ↗ |
| K101503 | DUSIMETRY CHECK | Math Resolutions, LLC | 2010-08-04 | Traditional | PDF ↗ |
| K100890 | VARIAN HIGH ENERGY LINEAR ACCELERATOR | Varian Medical Systems | 2010-07-13 | Special | PDF ↗ |
| K093967 | VARIAN TREATMENT | Varian Medical Systems, Inc. | 2010-07-12 | Traditional | PDF ↗ |
| K100801 | PUMA MODEL VERSION 1.0 | Prowess, Inc. | 2010-06-18 | Traditional | PDF ↗ |
| K101131 | FIDUCIAL MARKERS | Cosman Medical, Inc. | 2010-06-17 | Traditional | PDF ↗ |
Product code IYE · Class II · Radiology. Data: openFDA.