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 |
|---|---|---|---|
| Jul 28, 2015 | K151207 | Proton Immobilization Solution Orfit Industries NV, BE | IYE |
| Jul 1, 2015 | K150873 | CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System Accuray Incorporated | IYE |
| May 20, 2015 | K150848 | Dose Calculator Sun Nuclear Corporation | IYE |
| May 15, 2015 | K151097 | Active Breathing Coordinator Aktina Medical Corporation | IYE |
| May 8, 2015 | K150706 | VitalBeam Varian Medical Systems, Inc. | IYE |
| Mar 27, 2015 | K142420 | Patient Positioning Devices Macromedics BV, NL | IYE |
| Mar 26, 2015 | K142294 | FlexiMarc Marker Cortex Manufacturing, Inc. | IYE |
| Mar 4, 2015 | K143485 | iGuide 2.1 Medical Intelligence Medizintechnik GmbH, DE | IYE |
| Dec 19, 2014 | K143224 | TrueBeam-TrueBeam STx-Edge Varian Medical Systems, Inc. | IYE |
| Dec 11, 2014 | K142560 | Varian Head Frame Varian Medical Systems, Inc. | IYE |
| Dec 5, 2014 | K142431 | WaterProof PROFILER Sun Nuclear Corporation | IYE |
| Dec 5, 2014 | K142142 | QUALITY REPORTS Sun Nuclear Corporation | IYE |
| Nov 21, 2014 | 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. | IYE |
| Oct 8, 2014 | K141855 | CLARITY Elekta , Ltd., CA | IYE |
| Oct 2, 2014 | K142268 | Varian Verification System (VVS) Varian Medical Systems, Inc. | IYE |
| Sep 26, 2014 | K141800 | PERFRACTION Sun Nuclear Corporation | IYE |
| Sep 5, 2014 | K141572 | MOSAIQ ONCOLOGY INFORMATION SYSTEM Impac Medical Systems, Inc. | IYE |
| Sep 5, 2014 | K140528 | TRUE BEAM, TRUE BEAM STX, EDGE Varian Medical Systems, Inc. | IYE |
| Aug 27, 2014 | K141230 | DOSELAB PRO Mobius Medical Systems, LP | IYE |
| Aug 7, 2014 | K141787 | SAGITTILT Orfit Industries NV | IYE |
| Jun 27, 2014 | K140823 | PERMANENT BEACON TRANSPONDER/SOFT TISSUE BEACON TRANSPONDER Varian Medical Systems, Inc. | IYE |
| Jun 24, 2014 | K140660 | MOBIUS3D Mobius Medical Systems, LP | IYE |
| Apr 4, 2014 | K133572 | ARIA RADIATION THERAPY MANAGEMENT Varian Medical Systems, Inc. | IYE |
| Mar 14, 2014 | K133227 | SMART SEGMENTATION - KNOWLEDGE BASED CONTOURING Varian Medical Systems, Inc. | IYE |
| Mar 4, 2014 | K132908 | TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT ARCH BASE LOCK REPLACEMENT KIT Medtec, Inc. | IYE |
| Feb 28, 2014 | K132064 | BIOMARC FIDUCIAL MARKER Carbon Medical Technologies, Inc. | IYE |
| Feb 21, 2014 | 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. | IYE |
| Jan 31, 2014 | K133240 | VARIAN MULTILEAF COLLIMATOR Varian Medical Systems, Inc. | IYE |
| Nov 14, 2013 | K132605 | DOSIMETRY CHECK VERSION 4 RELEASE 1 Math Resolutions, LLC | IYE |
| Nov 1, 2013 | K132124 | KLARITY VACUUM BAG, KLARITY MOLD CUSHION Klarity Medical Products, LLC | IYE |
| Oct 31, 2013 | K132705 | UNIQUE Varian Medical Systems, Inc. | IYE |
| Oct 11, 2013 | K131807 | HIGH ENERGY LINEAR ACCELERATOR Varian Medical Systems, Inc. | IYE |
| Sep 26, 2013 | K131795 | NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS Orfit Industries NV, BE | IYE |
| Sep 25, 2013 | K131965 | XVI R5.0 Elekta Limited, GB | IYE |
| Aug 21, 2013 | K131862 | 3DVH Sun Nuclear Corporation | IYE |
| Aug 20, 2013 | K131466 | MAPCHECK2, ARCCHECK Sun Nuclear Corporation | IYE |
| Aug 7, 2013 | K131313 | ACTIVE BREATHING COORDINATOR Aktina Medical Corp. | IYE |
| Aug 5, 2013 | K131704 | EPIDOSE Sun Nuclear Corporation | IYE |
| Jun 14, 2013 | K130992 | PINNACLE3 RADIATION THERAPY PLANNING SYSTEM Philips Medical Systems (Cleveland), Inc. | IYE |
| Jun 14, 2013 | K121284 | CHABNER XRT GARMENTS Chabner Xrt, LLC | IYE |
| Apr 30, 2013 | K122888 | CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEM Cdr Systems, Inc., CA | IYE |
| Apr 12, 2013 | K130678 | BIOMARC GOLD FIDUCIAL MARKER Carbon Medical Technologies, Inc. | IYE |
| Apr 4, 2013 | K123808 | AGILITY Elekta , Ltd., GB | IYE |
| Mar 1, 2013 | K123812 | COHERENCE RT THERAPIST CONNECT WORKSPACE, V2.3, ARIA CONNECTIVITY OPTION FOR SIEMENS NON-IMAGING SYSTEMS, ARIA CONNECTIV Siemens Medical Solutions USA, Inc. | IYE |
| Jan 15, 2013 | K123788 | INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI) Varian Medical Systems, Inc. | IYE |
| Jan 8, 2013 | K123371 | ALIGNRT PLUS Vision RT Limited, GB | IYE |
| Dec 21, 2012 | K122616 | PANTHER OIS/R & V MODEL VERSION 2.0 Prowess, Inc. | IYE |
| Dec 20, 2012 | K123291 | TRUEBEAM Varian Medical Systems, Inc. | IYE |
| Dec 12, 2012 | K123230 | MOSAIQ ONCOLOGY INFORMATION SYSTEM Impac Medical Systems, Inc. | IYE |
| Dec 5, 2012 | K123137 | CALYPSO SYSTEM Varian Medical Systems | IYE |
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