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 23, 2023K223209Elekta Unity
Elekta Solutions AB, SE
IYE
Feb 17, 2023K222977DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip
Macromedics BV, NL
IYE
Jan 17, 2023K222941Halcyon, Ethos Radiotherapy System
Varian Medical Systems, Inc.
IYE
Nov 1, 2022K220539Klarity SRS Baseplate, Klarity Promise Baseplate
Klarity Medical & Equipment (GZ) Co., Ltd., CN
IYE
Aug 23, 2022K220583ClearCheck Model RADCC V2
Radformation, Inc.
IYE
Jun 24, 2022K213439FlexBoardTM, EagleBoardTM, BreastBoard SXTM
Macromedics BV, NL
IYE
Jun 17, 2022K221408ARIA Radiation Therapy Management (v16.1 MR3)
Varian Medical Systems, Inc.
IYE
Jun 15, 2022K221448ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8)
Varian Medical Systems, Inc.
IYE
Jun 3, 2022K213977TrueBeam, TrueBeam STx, Edge, VitalBeam
Varian Medical Systems, Inc.
IYE
May 13, 2022K213137INTDose
Carina Medical, LLC
IYE
May 11, 2022K212909VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips
Macromedics BV, NL
IYE
May 4, 2022K213526Aurora-RT
Magnettx Oncology Solutions , Ltd., CA
IYE
Apr 29, 2022K220338ExacTrac Dynamic
Brainlab AG, DE
IYE
Mar 30, 2022K213370VERIQA
Ptw-Freiburg Physikalisch-Technische-Werkstaetten, DE
IYE
Jan 6, 2022K213053Gold Anchor
Naslund Medical AB, SE
IYE
Dec 14, 2021K212958MRIdian Linac System
Viewray, Incorporated
IYE
Nov 10, 2021K212583AlignRT Plus
Vision Rt, Ltd., GB
IYE
Nov 2, 2021K210921TaiChiB
Our United Corporation, CN
IYE
Oct 1, 2021K212114Elekta Unity
Elekta Solutions AB, SE
IYE
Sep 30, 2021K212794Accuray Precision Treatment Planning System
Accuray Incorporated
IYE
Sep 28, 2021K211760Panther OIS
Prowess, Inc.
IYE
Sep 28, 2021K210894SIDDHARTH-II; IMPACT
Panacea Medical Technologies Pvt. , Ltd., IN
IYE
Sep 15, 2021K212606BeamSite
Doseoptics, LLC
IYE
Sep 2, 2021K203722RayPilot System
Micropos Medical AB, SE
IYE
Aug 20, 2021K212294Ethos Treatment Management, Ethos Treatment Planning
Varian Medical Systems, Inc.
IYE
Jul 29, 2021K211663Zap-X Radiosurgical System
Zap Surgical Systems, Inc.
IYE
Jul 22, 2021K211939ExacTrac Dynamic
Brainlab AG, DE
IYE
Jun 11, 2021K210500Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD
Elekta Limited, GB
IYE
Jun 10, 2021K211590Fiducial Marker
Carbon Medical Technologies, Inc.
IYE
May 20, 2021K211001C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner
Medtec, Inc. Dba Civco Medical Solutions and Civco
IYE
May 14, 2021K202747Klarity Bolus
Klarity Medical & Equipment (GZ) Co., Ltd., CN
IYE
Apr 20, 2021K210835Identify
Varian Medical Systems, Inc.
IYE
Mar 4, 2021K203387AlignRT Plus
Vision Rt, Ltd., GB
IYE
Jan 14, 2021K203669Mobius3D
Varian Medical Systems, Inc.
IYE
Dec 18, 2020K203172MOSAIQ Oncology Information System
Elekta Solutions AB, SE
IYE
Dec 18, 2020K202412ClearRT Helical kVCT for the Radixact Treatment Delivery System
Accuray Incorporated
IYE
Dec 11, 2020K200940BeamSite
Doseoptics, LLC
IYE
Nov 12, 2020K203173ExacTrac Dynamic
Brainlab AG, DE
IYE
Aug 19, 2020K202050Cranial 4Pi Immobilization
Brainlab AG, DE
IYE
Aug 14, 2020K202068The AIO Solution 3.0
Orfit Industries NV, BE
IYE
Aug 7, 2020K193207TaiChiA
Our United Corporation, CN
IYE
Jul 13, 2020K201276ExacTrac Dynamic
Brainlab AG, DE
IYE
Jul 6, 2020K200652Lollipop BiteBlock
Radtec Medical Devices, Inc.
IYE
Jun 26, 2020K201119ChartCheck
Radformation, Inc.
IYE
Jun 11, 2020K201117Gold Anchor
Naslund Medical AB, SE
IYE
Jun 3, 2020K200907Thales 3D Mr Scanner
Lap GmbH Laser Applikationen, DE
IYE
May 7, 2020K200435Catalyst+, Catalyst+ HD
C-Rad Positioning AB, SE
IYE
May 1, 2020K192405Image Guidance System for Radiotherapy
Jiangsu Rayer Medical Technology Co., Ltd., CN
IYE
Apr 20, 2020K200600Sentinel
C-Rad Positioning AB, SE
IYE
Mar 12, 2020K190978RefleXion Medical Radiotherapy System
Reflexion Medical, Inc.
IYE

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