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IYE

735 FDA 510(k) clearances · Product code

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RecordFirmDate
AlignRT Plus (K193431)Vision Rt, Ltd.2020-01-03
Medical Radiation Dosimetry System microSTARii (K192196)Landauer2019-12-27
Elekta Unity (K192482)Elekta Limited2019-12-05
Synergy Platform, Synergy, Infinity, VersaHD (K192242)Elekta Limited2019-11-22
IDENTIFY (K192968)Varian Medical Systems, Inc.2019-11-12
MU2net (K191944)Dosisoft2019-10-24
Mobius3D (K192424)Varian Medical Systems, Inc.2019-10-03
Thermoplastic Masks (K192102)Aktina Medical Corporation2019-09-25
The AIO Solution (K191158)Orfit Industries NV2019-08-06
ImagingRing System on Rails (K191267)Medphoton GmbH2019-08-01
Mobius3D (K191761)Varian Medical Systems, Inc.2019-07-31
BiomarC Fiducial Marker (K191797)Carbon Medical Technologies2019-07-29
Identify (K190137)Varian Medical Systems, Inc.2019-07-10
LIAC S (K182374)Sit Sordina Iort Technologies Spa2019-05-22
TOTIM Patient Cushion Immobilization System (K190894)Essebi Medical Srl2019-04-30
Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) (K183606)Scandidos AB2019-04-08
FibermarX Radiopaque Tissue Marker (K190155)Viscus Biologics, LLC2019-02-27
GrayDuck Stent (K183374)Poll Medical, LLC2019-02-26
Zap-X Radiosurgery System (K183698)Zap Surgical Systems2019-02-25
MRIdian Linac System (K181989)Viewray, Incorporated2019-02-20
MOSAIQ Oncology Information System (K183034)Elekta, Inc.2018-12-04
Elekta Unity (K182076)Elekta Limited2018-12-04
Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System (K182687)Accuray Incorporated2018-11-23
Encompass SRS Headframe ; Encompass MR SRS Headframe (K182189)Qfix2018-10-04
Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo Radiation Therapy Oncologist v4.3.1_MR3 Patch (K182050)Siemens Medical Solutions USA, Inc.2018-10-03
DORADOnova MR3T (K173926)Lap GmbH Laser Applikationen2018-09-14
Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask (K182079)Medtec Inc. Dba Civco Medical Solutions2018-09-07
Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD (K182138)Eleckta Limited2018-09-05
AlignRT Plus (K181218)Vision Rt, Ltd.2018-08-07
Model WP-3840 and WP-3040 (K173848)Cnmc Co., Inc.2018-08-07
ACCUSYTE 3D Fiducial Marker (K180027)Radiation Products, LLC2018-07-18
Pseudo-Patient (K180697)Rtsafe, Inc.2018-07-10
Proton Positioing and Immobilization Devices (K180021)Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap2018-06-29
Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator (K181404)Varian Medical Systems, Inc.2018-06-28
LIAC HWL (K172961)Sit Sordina Iort Technologies Spa2018-06-11
Halcyon (K181032)Varian Medical Systems, Inc.2018-05-09
Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung (K170570)Varian Medical Systems, Inc.2018-04-06
SciMoCa (K180595)Radialogica, LLC2018-04-04
Varian Head Frame (K180586)Varian Medical Systems, Inc.2018-04-02
ThinkQA (K180106)Dosisoft2018-03-13
ARIA Radiation Therapy Management (K173838)Varian Medical Systems, Inc.2018-01-17
LumiCoil Platinum Fiducial Marker (K173251)Boston Scientific Corporation2017-12-19
EZFluence (K171352)Radformation, Inc.2017-12-01
Collision Check (K171350)Radformation, Inc.2017-11-29
BioZorb Marker GOLD / LP Marker GOLD (K171467)Focal Therapeutics2017-11-09
SOFTDISO (K170345)Best Nomos2017-10-27
LINACwatch, LinacView (K172534)Qualiformed Sarl2017-10-27
SunCHECK (K170307)Sun Nuclear Corporation2017-10-25
OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D (K160405)Ptw-Freiburg Physikalisch-Technische-Werkstaetten2017-10-20
Zap-X Radiosurgery System (K171804)Zap Surgical Systems2017-09-21
VitalBeam (K172013)Varian Medical Systems, Inc.2017-07-28
HP PRO Positioning Device (K171734)Orfit Industries NV2017-07-25
TomoTherapy Treatment Delivery System with iDMS (K171837)Accuray Incorporated2017-07-25
TrueBeam, TrueBeam STx, Edge (K171733)Varian Medical Systems, Inc.2017-07-12
Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories (K171133)Qfix2017-07-11
Halcyon (K170817)Varian Medical Systems, Inc.2017-06-27
Accuray Precision Treatment Planning System (K171086)Accuray Incorporated2017-06-08
MRIdian Linac System with 138-leaf Collimator (K170751)Viewray, Incorporated2017-06-07
BEAMSCAN (K161807)Ptw-Freiburg Physikalisch Technische-Werksraetten2017-05-19
Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) (K161724)Radiomed Corporation2017-04-28
CyberKnife Treatment Delivery System (K170788)Accuray Incorportaed2017-04-11
TheraView TBI (K170058)Cablon Medical B.V.2017-03-03
The ViewRay (MRIdian) Linac System (K162393)Viewray, Incorporated2017-02-24
TrueBeam-TrueBeam STx-Edge (K162472)Varian Medical Systems, Inc.2017-01-19
Varian High Energy Linear Accelerator (K162476)Varian Medical Systems, Inc.2016-12-12
ImagingRing System (K161400)Medphoton GmbH2016-12-08
ClearCheck (K162468)Radformation2016-12-01
Raycast MammoRx Carbon Fibre Breast Board (K162355)Orfit Industries NV2016-11-22
Dosimetry Check Version 5 Release 1 (K162577)Math Resolutions, LLC2016-11-18
CushionCast Moldable Cushions (K162265)Izi Medical Products, LLC2016-11-15
Raycast High Precision Lung Board Solution (K162862)Orfit Industries NV2016-11-09
Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay (K162002)Zdi, Solutions, LLC2016-11-01
IQM Integral Quality Monitor (also IQM) (K162629)Irt Systems2016-10-20
Interlocked Circular Small Field Collimators, Elekta Integrated (K161984)Aktina Medical Corporation2016-09-27
DoseCHECK (K161946)Sun Nuclear Corporation2016-09-16
Radixact Treatment Delivery System (K161146)Accuray Incorporated2016-06-24
iDMS Data Management System (K161144)Accuray Incorporated2016-06-24
Gold Anchor (K160209)Naslund Medical AB2016-06-21
Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solution (K160627)Qfix2016-06-14
Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement (K153026)Medtec, Inc. D/B/A Civco Medical Solutions2016-05-25
ArcCHECK-MR (K160057)Sun Nuclear Corporation2016-05-13
Mobius3D (K153014)Mobius Medical Systems, LP2016-04-29
TruGuard Custom Tongue and Jaw Positioner (K153270)Bionix Development Corp.2016-03-08
Adaptivo (K152994)Aurora Technology Development, LLC2016-02-03
ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+ (K151426)Scandidos AB2016-01-29
iViewDose R1.0 (K153011)Elekta Limited2015-12-11
kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracranial Fibreplast Variable Perf Head Only Open View with 119 mm opening (K152321)Qfix2015-12-04
Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft Tissue (17G) (K152761)Varian Medical Systems, Inc.2015-11-25
ArcCHECK (K142617)Sun Nuclear Corporation2015-11-20
Thermofit (K151946)Orfit Industries2015-11-09
Varian Treatment (VTx) (K151882)Varian Medical Systems, Inc.2015-10-26
MHI-TM2000 Linear Accelerator System, VERO, Imavis (K152867)Mitsubishi Heavy Industries, Ltd.2015-10-21
CygneX I System (K143560)Accuthera, Inc.2015-10-05
Radio Therapy Treatment Chair (K150382)Radiation Products Design, Inc.2015-09-16
Model 206 Electrometer/Dosimeter (K150265)Cnmc Company Incorporated2015-09-03
ScandiDos Delta4 Phantom+ (K151180)Scandidos AB2015-08-19
EDOSE (K150767)Guangzhou Raydose Software Technology., LLC2015-08-17
Proton Immobilization Solution (K151207)Orfit Industries NV2015-07-28
CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System (K150873)Accuray Incorporated2015-07-01
Dose Calculator (K150848)Sun Nuclear Corporation2015-05-20
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