ClearanceBrief
Panels › Radiology › Product code IYE · Class 2

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)
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Top companies in IYE

Company510(k)sRecalls
Siemens Medical Solutions USA, Inc.18206
Varian Medical Systems8327
Elekta , Ltd.1977
Varian Medical Systems, Oncology Systems268
Accuray Incorporated1932
Landauer139
Brainlab2217
Varian Assoc., Inc.270
Medtec, Inc.200
Sun Nuclear Corp.191
Decided510(k)Device and applicantCode
Feb 28, 2020K193243Alta Multipurpose Device
Qfix
IYE
Feb 21, 2020K191646Beamscan MR
Ptw-Freiburg Physikalisch-Technische-Werkstaetten, DE
IYE
Feb 10, 2020K192377Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon
Varian Medical Systems, Inc.
IYE
Jan 3, 2020K193431AlignRT Plus
Vision Rt, Ltd., GB
IYE
Dec 27, 2019K192196Medical Radiation Dosimetry System microSTARii
Landauer
IYE
Dec 5, 2019K192482Elekta Unity
Elekta Limited, GB
IYE
Nov 22, 2019K192242Synergy Platform, Synergy, Infinity, VersaHD
Elekta Limited, GB
IYE
Nov 12, 2019K192968IDENTIFY
Varian Medical Systems, Inc.
IYE
Oct 24, 2019K191944MU2net
Dosisoft, FR
IYE
Oct 3, 2019K192424Mobius3D
Varian Medical Systems, Inc.
IYE
Sep 25, 2019K192102Thermoplastic Masks
Aktina Medical Corporation
IYE
Aug 6, 2019K191158The AIO Solution
Orfit Industries NV, BE
IYE
Aug 1, 2019K191267ImagingRing System on Rails
Medphoton GmbH, AT
IYE
Jul 31, 2019K191761Mobius3D
Varian Medical Systems, Inc.
IYE
Jul 29, 2019K191797BiomarC Fiducial Marker
Carbon Medical Technologies
IYE
Jul 10, 2019K190137Identify
Varian Medical Systems, Inc.
IYE
May 22, 2019K182374LIAC S
Sit Sordina Iort Technologies Spa, IT
IYE
Apr 30, 2019K190894TOTIM Patient Cushion Immobilization System
Essebi Medical Srl, SM
IYE
Apr 8, 2019K183606Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)
Scandidos AB, SE
IYE
Feb 27, 2019K190155FibermarX Radiopaque Tissue Marker
Viscus Biologics, LLC
IYE
Feb 26, 2019K183374GrayDuck Stent
Poll Medical, LLC
IYE
Feb 25, 2019K183698Zap-X Radiosurgery System
Zap Surgical Systems
IYE
Feb 20, 2019K181989MRIdian Linac System
Viewray, Incorporated
IYE
Dec 4, 2018K183034MOSAIQ Oncology Information System
Elekta, Inc.
IYE
Dec 4, 2018K182076Elekta Unity
Elekta Limited, GB
IYE
Nov 23, 2018K182687Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System
Accuray Incorporated
IYE
Oct 4, 2018K182189Encompass SRS Headframe ; Encompass MR SRS Headframe
Qfix
IYE
Oct 3, 2018K182050Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo
Siemens Medical Solutions USA, Inc.
IYE
Sep 14, 2018K173926DORADOnova MR3T
Lap GmbH Laser Applikationen, DE
IYE
Sep 7, 2018K182079Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask
Medtec Inc. Dba Civco Medical Solutions
IYE
Sep 5, 2018K182138Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD
Eleckta Limited, GB
IYE
Aug 7, 2018K181218AlignRT Plus
Vision Rt, Ltd., GB
IYE
Aug 7, 2018K173848Model WP-3840 and WP-3040
Cnmc Co., Inc.
IYE
Jul 18, 2018K180027ACCUSYTE 3D Fiducial Marker
Radiation Products, LLC
IYE
Jul 10, 2018K180697Pseudo-Patient
Rtsafe, Inc.
IYE
Jun 29, 2018K180021Proton Positioing and Immobilization Devices
Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap
IYE
Jun 28, 2018K181404Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator
Varian Medical Systems, Inc.
IYE
Jun 11, 2018K172961LIAC HWL
Sit Sordina Iort Technologies Spa, IT
IYE
May 9, 2018K181032Halcyon
Varian Medical Systems, Inc.
IYE
Apr 6, 2018K170570Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung
Varian Medical Systems, Inc.
IYE
Apr 4, 2018K180595SciMoCa
Radialogica, LLC
IYE
Apr 2, 2018K180586Varian Head Frame
Varian Medical Systems, Inc.
IYE
Mar 13, 2018K180106ThinkQA
Dosisoft, FR
IYE
Jan 17, 2018K173838ARIA Radiation Therapy Management
Varian Medical Systems, Inc.
IYE
Dec 19, 2017K173251LumiCoil Platinum Fiducial Marker
Boston Scientific Corporation
IYE
Dec 1, 2017K171352EZFluence
Radformation, Inc.
IYE
Nov 29, 2017K171350Collision Check
Radformation, Inc.
IYE
Nov 9, 2017K171467BioZorb Marker GOLD / LP Marker GOLD
Focal Therapeutics
IYE
Oct 27, 2017K172534LINACwatch, LinacView
Qualiformed Sarl, FR
IYE
Oct 27, 2017K170345SOFTDISO
Best Nomos
IYE

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