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Accelerator, Linear, Medical

FDA product code IYE · 698 cleared devices

Class 2 Radiology

Regulation: 21 CFR 892.5050
Review panel: RA
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-08-03 – 2026-09-16

IYE 2020-02-28

Alta Multipurpose Device

Applicant Qfix

K number K193243

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IYE 2020-02-21

Beamscan MR

Applicant Ptw-Freiburg Physikalisch-Technische-Werkstaetten

K number K191646

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IYE 2020-02-10

Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon

Applicant Varian Medical Systems, Inc.

K number K192377

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IYE 2020-01-03

AlignRT Plus

Applicant Vision Rt, Ltd.

K number K193431

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IYE 2019-12-27

Medical Radiation Dosimetry System microSTARii

Applicant Landauer

K number K192196

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IYE 2019-12-05

Elekta Unity

Applicant Elekta Limited

K number K192482

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IYE 2019-11-22

Synergy Platform, Synergy, Infinity, VersaHD

Applicant Elekta Limited

K number K192242

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IYE 2019-11-12

IDENTIFY

Applicant Varian Medical Systems, Inc.

K number K192968

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IYE 2019-10-24

MU2net

Applicant Dosisoft

K number K191944

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IYE 2019-10-03

Mobius3D

Applicant Varian Medical Systems, Inc.

K number K192424

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IYE 2019-09-25

Thermoplastic Masks

Applicant Aktina Medical Corporation

K number K192102

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IYE 2019-08-06

The AIO Solution

Applicant Orfit Industries NV

K number K191158

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IYE 2019-08-01

ImagingRing System on Rails

Applicant Medphoton GmbH

K number K191267

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IYE 2019-07-31

Mobius3D

Applicant Varian Medical Systems, Inc.

K number K191761

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IYE 2019-07-29

BiomarC Fiducial Marker

Applicant Carbon Medical Technologies

K number K191797

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IYE 2019-07-10

Identify

Applicant Varian Medical Systems, Inc.

K number K190137

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IYE 2019-05-22

LIAC S

Applicant Sit Sordina Iort Technologies Spa

K number K182374

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IYE 2019-04-30

TOTIM Patient Cushion Immobilization System

Applicant Essebi Medical Srl

K number K190894

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IYE 2019-04-08

Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)

Applicant Scandidos AB

K number K183606

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IYE 2019-02-27

FibermarX Radiopaque Tissue Marker

Applicant Viscus Biologics, LLC

K number K190155

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IYE 2019-02-26

GrayDuck Stent

Applicant Poll Medical, LLC

K number K183374

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IYE 2019-02-25

Zap-X Radiosurgery System

Applicant Zap Surgical Systems

K number K183698

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IYE 2019-02-20

MRIdian Linac System

Applicant Viewray, Incorporated

K number K181989

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IYE 2018-12-04

MOSAIQ Oncology Information System

Applicant Elekta, Inc.

K number K183034

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IYE 2018-12-04

Elekta Unity

Applicant Elekta Limited

K number K182076

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IYE 2018-11-23

Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System

Applicant Accuray Incorporated

K number K182687

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IYE 2018-10-04

Encompass SRS Headframe ; Encompass MR SRS Headframe

Applicant Qfix

K number K182189

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IYE 2018-10-03

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

Applicant Siemens Medical Solutions USA, Inc.

K number K182050

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IYE 2018-09-14

DORADOnova MR3T

Applicant Lap GmbH Laser Applikationen

K number K173926

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IYE 2018-09-07

Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask

Applicant Medtec Inc. Dba Civco Medical Solutions

K number K182079

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IYE 2018-09-05

Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD

Applicant Eleckta Limited

K number K182138

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IYE 2018-08-07

AlignRT Plus

Applicant Vision Rt, Ltd.

K number K181218

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IYE 2018-08-07

Model WP-3840 and WP-3040

Applicant Cnmc Co., Inc.

K number K173848

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IYE 2018-07-18

ACCUSYTE 3D Fiducial Marker

Applicant Radiation Products, LLC

K number K180027

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IYE 2018-07-10

Pseudo-Patient

Applicant Rtsafe, Inc.

K number K180697

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IYE 2018-06-29

Proton Positioing and Immobilization Devices

Applicant Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap

K number K180021

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IYE 2018-06-28

Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator

Applicant Varian Medical Systems, Inc.

K number K181404

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IYE 2018-06-11

LIAC HWL

Applicant Sit Sordina Iort Technologies Spa

K number K172961

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IYE 2018-05-09

Halcyon

Applicant Varian Medical Systems, Inc.

K number K181032

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IYE 2018-04-06

Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung

Applicant Varian Medical Systems, Inc.

K number K170570

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IYE 2018-04-04

SciMoCa

Applicant Radialogica, LLC

K number K180595

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IYE 2018-04-02

Varian Head Frame

Applicant Varian Medical Systems, Inc.

K number K180586

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IYE 2018-03-13

ThinkQA

Applicant Dosisoft

K number K180106

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IYE 2018-01-17

ARIA Radiation Therapy Management

Applicant Varian Medical Systems, Inc.

K number K173838

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IYE 2017-12-19

LumiCoil Platinum Fiducial Marker

Applicant Boston Scientific Corporation

K number K173251

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IYE 2017-12-01

EZFluence

Applicant Radformation, Inc.

K number K171352

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IYE 2017-11-29

Collision Check

Applicant Radformation, Inc.

K number K171350

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IYE 2017-11-09

BioZorb Marker GOLD / LP Marker GOLD

Applicant Focal Therapeutics

K number K171467

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IYE 2017-10-27

LINACwatch, LinacView

Applicant Qualiformed Sarl

K number K172534

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IYE 2017-10-27

SOFTDISO

Applicant Best Nomos

K number K170345

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IYE 2017-10-25

SunCHECK

Applicant Sun Nuclear Corporation

K number K170307

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IYE 2017-10-20

OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D

Applicant Ptw-Freiburg Physikalisch-Technische-Werkstaetten

K number K160405

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IYE 2017-09-21

Zap-X Radiosurgery System

Applicant Zap Surgical Systems

K number K171804

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IYE 2017-07-28

VitalBeam

Applicant Varian Medical Systems, Inc.

K number K172013

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IYE 2017-07-25

TomoTherapy Treatment Delivery System with iDMS

Applicant Accuray Incorporated

K number K171837

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IYE 2017-07-25

HP PRO Positioning Device

Applicant Orfit Industries NV

K number K171734

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IYE 2017-07-12

TrueBeam, TrueBeam STx, Edge

Applicant Varian Medical Systems, Inc.

K number K171733

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IYE 2017-07-11

Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories

Applicant Qfix

K number K171133

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IYE 2017-06-27

Halcyon

Applicant Varian Medical Systems, Inc.

K number K170817

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IYE 2017-06-08

Accuray Precision Treatment Planning System

Applicant Accuray Incorporated

K number K171086

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IYE 2017-06-07

MRIdian Linac System with 138-leaf Collimator

Applicant Viewray, Incorporated

K number K170751

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IYE 2017-05-19

BEAMSCAN

Applicant Ptw-Freiburg Physikalisch Technische-Werksraetten

K number K161807

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IYE 2017-04-28

Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)

Applicant Radiomed Corporation

K number K161724

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IYE 2017-04-11

CyberKnife Treatment Delivery System

Applicant Accuray Incorportaed

K number K170788

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IYE 2017-03-03

TheraView TBI

Applicant Cablon Medical B.V.

K number K170058

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IYE 2017-02-24

The ViewRay (MRIdian) Linac System

Applicant Viewray, Incorporated

K number K162393

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IYE 2017-01-19

TrueBeam-TrueBeam STx-Edge

Applicant Varian Medical Systems, Inc.

K number K162472

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IYE 2016-12-12

Varian High Energy Linear Accelerator

Applicant Varian Medical Systems, Inc.

K number K162476

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IYE 2016-12-08

ImagingRing System

Applicant Medphoton GmbH

K number K161400

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IYE 2016-12-01

ClearCheck

Applicant Radformation

K number K162468

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IYE 2016-11-22

Raycast MammoRx Carbon Fibre Breast Board

Applicant Orfit Industries NV

K number K162355

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IYE 2016-11-18

Dosimetry Check Version 5 Release 1

Applicant Math Resolutions, LLC

K number K162577

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IYE 2016-11-15

CushionCast Moldable Cushions

Applicant Izi Medical Products, LLC

K number K162265

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IYE 2016-11-09

Raycast High Precision Lung Board Solution

Applicant Orfit Industries NV

K number K162862

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IYE 2016-11-01

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

Applicant Zdi, Solutions, LLC

K number K162002

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IYE 2016-10-20

IQM Integral Quality Monitor (also IQM)

Applicant Irt Systems

K number K162629

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IYE 2016-09-27

Interlocked Circular Small Field Collimators, Elekta Integrated

Applicant Aktina Medical Corporation

K number K161984

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IYE 2016-09-16

DoseCHECK

Applicant Sun Nuclear Corporation

K number K161946

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IYE 2016-06-24

Radixact Treatment Delivery System

Applicant Accuray Incorporated

K number K161146

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IYE 2016-06-24

iDMS Data Management System

Applicant Accuray Incorporated

K number K161144

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IYE 2016-06-21

Gold Anchor

Applicant Naslund Medical AB

K number K160209

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IYE 2016-06-14

Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solution

Applicant Qfix

K number K160627

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IYE 2016-05-25

Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement

Applicant Medtec, Inc. D/B/A Civco Medical Solutions

K number K153026

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IYE 2016-05-13

ArcCHECK-MR

Applicant Sun Nuclear Corporation

K number K160057

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IYE 2016-04-29

Mobius3D

Applicant Mobius Medical Systems, LP

K number K153014

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IYE 2016-03-08

TruGuard Custom Tongue and Jaw Positioner

Applicant Bionix Development Corp.

K number K153270

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IYE 2016-02-03

Adaptivo

Applicant Aurora Technology Development, LLC

K number K152994

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IYE 2016-01-29

ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+

Applicant Scandidos AB

K number K151426

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IYE 2013-11-14

DOSIMETRY CHECK VERSION 4 RELEASE 1

Applicant Math Resolutions, LLC

K number K132605

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IYE 2013-11-01

KLARITY VACUUM BAG, KLARITY MOLD CUSHION

Applicant Klarity Medical Products, LLC

K number K132124

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IYE 2013-10-31

UNIQUE

Applicant Varian Medical Systems, Inc.

K number K132705

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IYE 2013-10-11

HIGH ENERGY LINEAR ACCELERATOR

Applicant Varian Medical Systems, Inc.

K number K131807

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IYE 2013-09-26

NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS

Applicant Orfit Industries NV

K number K131795

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IYE 2013-09-25

XVI R5.0

Applicant Elekta Limited

K number K131965

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IYE 2013-08-21

3DVH

Applicant Sun Nuclear Corporation

K number K131862

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IYE 2013-08-20

MAPCHECK2, ARCCHECK

Applicant Sun Nuclear Corporation

K number K131466

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IYE 2013-08-07

ACTIVE BREATHING COORDINATOR

Applicant Aktina Medical Corp.

K number K131313

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IYE 2013-08-05

EPIDOSE

Applicant Sun Nuclear Corporation

K number K131704

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IYE 2013-06-14

PINNACLE3 RADIATION THERAPY PLANNING SYSTEM

Applicant Philips Medical Systems (Cleveland), Inc.

K number K130992

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IYE 2013-06-14

CHABNER XRT GARMENTS

Applicant Chabner Xrt, LLC

K number K121284

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