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 |
|---|---|---|---|
| Oct 25, 2017 | K170307 | SunCHECK Sun Nuclear Corporation | IYE |
| Oct 20, 2017 | K160405 | OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D Ptw-Freiburg Physikalisch-Technische-Werkstaetten, DE | IYE |
| Sep 21, 2017 | K171804 | Zap-X Radiosurgery System Zap Surgical Systems | IYE |
| Jul 28, 2017 | K172013 | VitalBeam Varian Medical Systems, Inc. | IYE |
| Jul 25, 2017 | K171837 | TomoTherapy Treatment Delivery System with iDMS Accuray Incorporated | IYE |
| Jul 25, 2017 | K171734 | HP PRO Positioning Device Orfit Industries NV, BE | IYE |
| Jul 12, 2017 | K171733 | TrueBeam, TrueBeam STx, Edge Varian Medical Systems, Inc. | IYE |
| Jul 11, 2017 | K171133 | Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories Qfix | IYE |
| Jun 27, 2017 | K170817 | Halcyon Varian Medical Systems, Inc. | IYE |
| Jun 8, 2017 | K171086 | Accuray Precision Treatment Planning System Accuray Incorporated | IYE |
| Jun 7, 2017 | K170751 | MRIdian Linac System with 138-leaf Collimator Viewray, Incorporated | IYE |
| May 19, 2017 | K161807 | BEAMSCAN Ptw-Freiburg Physikalisch Technische-Werksraetten, DE | IYE |
| Apr 28, 2017 | K161724 | Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) Radiomed Corporation | IYE |
| Apr 11, 2017 | K170788 | CyberKnife Treatment Delivery System Accuray Incorportaed | IYE |
| Mar 3, 2017 | K170058 | TheraView TBI Cablon Medical B.V., NL | IYE |
| Feb 24, 2017 | K162393 | The ViewRay (MRIdian) Linac System Viewray, Incorporated | IYE |
| Jan 19, 2017 | K162472 | TrueBeam-TrueBeam STx-Edge Varian Medical Systems, Inc. | IYE |
| Dec 12, 2016 | K162476 | Varian High Energy Linear Accelerator Varian Medical Systems, Inc. | IYE |
| Dec 8, 2016 | K161400 | ImagingRing System Medphoton GmbH, AT | IYE |
| Dec 1, 2016 | K162468 | ClearCheck Radformation | IYE |
| Nov 22, 2016 | K162355 | Raycast MammoRx Carbon Fibre Breast Board Orfit Industries NV, BE | IYE |
| Nov 18, 2016 | K162577 | Dosimetry Check Version 5 Release 1 Math Resolutions, LLC | IYE |
| Nov 15, 2016 | K162265 | CushionCast Moldable Cushions Izi Medical Products, LLC | IYE |
| Nov 9, 2016 | K162862 | Raycast High Precision Lung Board Solution Orfit Industries NV, BE | IYE |
| Nov 1, 2016 | K162002 | Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Zdi, Solutions, LLC | IYE |
| Oct 20, 2016 | K162629 | IQM Integral Quality Monitor (also IQM) Irt Systems, DE | IYE |
| Sep 27, 2016 | K161984 | Interlocked Circular Small Field Collimators, Elekta Integrated Aktina Medical Corporation | IYE |
| Sep 16, 2016 | K161946 | DoseCHECK Sun Nuclear Corporation | IYE |
| Jun 24, 2016 | K161146 | Radixact Treatment Delivery System Accuray Incorporated | IYE |
| Jun 24, 2016 | K161144 | iDMS Data Management System Accuray Incorporated | IYE |
| Jun 21, 2016 | K160209 | Gold Anchor Naslund Medical AB, SE | IYE |
| Jun 14, 2016 | K160627 | Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head Qfix | IYE |
| May 25, 2016 | K153026 | Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, P Medtec, Inc. D/B/A Civco Medical Solutions | IYE |
| May 13, 2016 | K160057 | ArcCHECK-MR Sun Nuclear Corporation | IYE |
| Apr 29, 2016 | K153014 | Mobius3D Mobius Medical Systems, LP | IYE |
| Mar 8, 2016 | K153270 | TruGuard Custom Tongue and Jaw Positioner Bionix Development Corp. | IYE |
| Feb 3, 2016 | K152994 | Adaptivo Aurora Technology Development, LLC | IYE |
| Jan 29, 2016 | K151426 | ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+ Scandidos AB, SE | IYE |
| Dec 11, 2015 | K153011 | iViewDose R1.0 Elekta Limited, GB | IYE |
| Dec 4, 2015 | K152321 | kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilizat Qfix | IYE |
| Nov 25, 2015 | K152761 | Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft Tissue (17G) Varian Medical Systems, Inc. | IYE |
| Nov 20, 2015 | K142617 | ArcCHECK Sun Nuclear Corporation | IYE |
| Nov 9, 2015 | K151946 | Thermofit Orfit Industries, BE | IYE |
| Oct 26, 2015 | K151882 | Varian Treatment (VTx) Varian Medical Systems, Inc. | IYE |
| Oct 21, 2015 | K152867 | MHI-TM2000 Linear Accelerator System, VERO, Imavis Mitsubishi Heavy Industries, Ltd., JP | IYE |
| Oct 5, 2015 | K143560 | CygneX I System Accuthera, Inc., JP | IYE |
| Sep 16, 2015 | K150382 | Radio Therapy Treatment Chair Radiation Products Design, Inc. | IYE |
| Sep 3, 2015 | K150265 | Model 206 Electrometer/Dosimeter Cnmc Company Incorporated | IYE |
| Aug 19, 2015 | K151180 | ScandiDos Delta4 Phantom+ Scandidos AB, SE | IYE |
| Aug 17, 2015 | K150767 | EDOSE Guangzhou Raydose Software Technology., LLC, CN | IYE |
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