Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 2008-05-09

VERISUITE 1.6, VERISUITE-PARTICLE 1.6

Applicant Medcom GmbH

K number K080742

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IYE 2008-01-23

STEREOTACTIC TARGET POSITIONER, TARGET POSITIONER FOR LEKSELL HEADRING, STEREOTACTIC COUNTERWEIGHT

Applicant Brainlab AG

K number K073018

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IYE 2007-12-27

ARTISTE MV SA

Applicant Siemens Medical Solutions USA, Inc.

K number K072485

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IYE 2007-12-11

EQUAL DOSE 1.0

Applicant Nucletron Corporation

K number K073273

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IYE 2007-12-07

COMPASS

Applicant Scanditronix Wellhofer GmbH

K number K072374

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IYE 2007-11-09

TRILOGY SYSTEM WITH RAPIDARC

Applicant Varian Medical Systems, Inc.

K number K072916

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IYE 2007-10-26

TRACKPORT

Applicant Direx Systems Corp.

K number K072529

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IYE 2007-10-26

EXACTRAC 5.5

Applicant Brainlab AG

K number K072506

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IYE 2007-10-17

EXACTRAC 3RD PARTY, EXACTRAC X-RAY 6D 3RD PARTY, EXACTRAC OEM

Applicant Brainlab AG

K number K072046

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IYE 2007-10-16

INTEGRA RADIONICS INTERFIX PATIENT ADAPTERS

Applicant Integra Radionics, Inc.

K number K072454

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IYE 2007-10-01

GATECT-RT

Applicant Vision RT Limited

K number K072171

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IYE 2007-09-21

CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM

Applicant Accuray Incorporated

K number K072504

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IYE 2007-09-11

FIDUCIAL MARKERS

Applicant Civco

K number K071614

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IYE 2007-08-29

MHI-TM2000 LINEAR ACCELERATOR SYSTEM

Applicant Mitsubishi Heavy Industries, Ltd.

K number K072047

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IYE 2007-08-22

MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM

Applicant Accuray Incorporated

K number K071531

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IYE 2007-08-15

HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC)

Applicant Varian Medical Systems

K number K071992

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IYE 2007-08-14

IGUIDE SYSTEM

Applicant Medical Intelligence Medizintechnik-GmbH-An Elekta

K number K072079

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IYE 2007-07-23

TRACKLEAF-10

Applicant Direx Systems Corp.

K number K071701

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IYE 2007-07-18

ONC SOLUTIONS MARKER, MODELS 001001 TO 001012 AND 001021 TO 001032

Applicant Onc Solutions, Inc.

K number K071673

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IYE 2007-07-11

BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM, VERSION 6

Applicant Nomos Corp.

K number K070611

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IYE 2007-06-08

OPTICAL GUIDANCE PLATFORM

Applicant Varian Medical Systems, Inc.

K number K071360

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IYE 2007-05-22

FUJI IP CASSETTE TYPE PC

Applicant Fujifilm Medical Systems U.S.A, Inc.

K number K070920

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IYE 2007-03-07

PRE-LOADED VISICOIL

Applicant Radiomed Corporation

K number K070305

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IYE 2007-02-09

TRILOGY RADIOTHERAPY DELIVERY SYSTEM AND TRILOGY TX DELIVERY SYSTEM

Applicant Varian Medical Systems, Inc.

K number K070094

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IYE 2007-02-08

POSITIONER

Applicant C-Rad Positioning AB

K number K063839

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IYE 2006-12-14

RPM RESPIRATORY GATING SYSTEM

Applicant Varian Medical Systems, Inc.

K number K063270

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IYE 2006-12-12

ACCULOC BREAST LOCALIZATION SYSTEM

Applicant Northwest Medical Physics Equipment, Inc.

K number K063274

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IYE 2006-11-22

PROFILER 2

Applicant Sun Nuclear Corp.

K number K063021

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IYE 2006-11-22

PTW DAVID IMRT QC VERIFICATION SYSTEM

Applicant Ptw-New York Corp.

K number K062817

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IYE 2006-09-22

TRILOGY TX WITH 3RD PARTY COUCH TOP SUPPORT

Applicant Varian Medical Systems, Inc.

K number K062618

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IYE 2006-09-20

IGUIDE SYSTEM

Applicant Medical Intelligence Medizintechnik-GmbH-An Elekta

K number K062611

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IYE 2006-07-28

CALYPSO 4D LOCALIZATION SYSTEM

Applicant Calypso Medical Technologies, Inc.

K number K060906

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IYE 2006-07-21

MAGIS1;MAGIS2

Applicant Direx Systems Corp.

K number K061713

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IYE 2006-07-21

NOMOSSTAT, VERSION 1.0

Applicant Nomos Corp.

K number K060895

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IYE 2006-05-15

TRILOGY RADIOTHERAPY DELIVERY SYSTEM

Applicant Varian Medical Systems

K number K061140

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IYE 2006-05-01

COHERENCE ONCOLOGIST WORKSPACE, MODEL 2.0 AND PHYSICIST WORKSPACE, MODEL 1.0

Applicant Siemens Medical Solutions USA, Inc.

K number K060633

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IYE 2006-04-19

MODIFICATION TO: HI-ART SYSTEM

Applicant Tomotherapy Incorporated

K number K060912

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IYE 2006-03-31

SINMED POSITIONING DEVICES

Applicant Sinmed BV

K number K060737

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IYE 2006-03-15

ONCOR EXPRESSION

Applicant Siemens Medical Solutions USA, Inc.

K number K060226

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IYE 2006-03-10

MIGUE

Applicant Direx Systems Corp.

K number K052212

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IYE 2006-02-21

DART-12

Applicant Direx Systems Corp.

K number K052705

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IYE 2006-02-03

FRAMELESS RADIOSURGERY COMPONENTS

Applicant Brainlab AG

K number K053500

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IYE 2006-01-12

DELTA4

Applicant Scandidos AB

K number K052920

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IYE 2006-01-06

ALIGNRT

Applicant Vision RT Limited

K number K052682

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IYE 2005-11-23

VISION (WITH OFF-LINE REVIEW)

Applicant Varian Medical Systems

K number K052391

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IYE 2005-09-30

IPLAN RT FIBERTRACKING

Applicant Brainlab AG

K number K052220

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IYE 2005-08-12

ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5

Applicant Elekta, Inc.

K number K051932

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IYE 2005-07-27

THE EDGE DETECTOR, MODEL 1118

Applicant Sun Nuclear Corp.

K number K051921

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IYE 2005-07-01

NAVIGATOR

Applicant Nomos Corp.

K number K042875

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IYE 2005-05-23

INTEGRA IMMOBILIZATION SYSTEM

Applicant Diacor, Inc.

K number K050888

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IYE 2005-05-05

ACCUCHANGER

Applicant Direx Systems Corp.

K number K043409

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IYE 2005-04-01

THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010

Applicant Bionix Development Corp.

K number K050701

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IYE 2005-03-25

VISITRAK, VERSION 1, RELEASE 1

Applicant Math Resolutions, LLC

K number K050372

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IYE 2005-03-24

4D INTEGRATED TREATMENT CONSOLE

Applicant Varian Medical Systems

K number K050479

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IYE 2005-03-23

MILLENNIUM MULTI-LEAF COLLIMATOR

Applicant Varian Medical Systems

K number K050442

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IYE 2005-03-11

VISION

Applicant Varian Medical Systems, Inc.

K number K042956

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IYE 2005-01-31

BEAM MODULATOR, MODEL 4513 332 8000

Applicant Elekta , Ltd.

K number K042794

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IYE 2004-11-16

RESTITU

Applicant Resonant Medical, Inc.

K number K041937

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IYE 2004-10-29

ON-BOARD IMAGER DEVICE

Applicant Varian Medical Systems

K number K042720

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IYE 2004-08-04

MODIFICATION TO: ON-BOARD IMAGER DEVICE

Applicant Varian Medical Systems, Inc.

K number K041519

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IYE 2004-06-25

MOBILEMOSFET WIRELESS DOSIMETRY SYSTEM, MODEL TN-RD-70-W

Applicant Thomson & Nielsen Electronics, Ltd.

K number K041557

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IYE 2004-06-25

ONEDOSE PATIENT DOSIMETRY SYSTEM

Applicant Sicel Technologies, Inc.

K number K040687

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IYE 2004-06-10

CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY

Applicant Accuray, Inc.

K number K041315

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IYE 2004-05-11

EXACTRAC 4.0 AND EXACTRAC X-RAY 6D

Applicant Brainlab AG

K number K040585

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IYE 2004-04-28

PROTOS SOFTWARE

Applicant Aktina Medical Physics Corp.

K number K040709

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IYE 2004-04-09

PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM

Applicant Bionix Development Corp.

K number K040773

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IYE 2004-04-05

DYNATRAC, COD. 50-1A

Applicant 3D Line USA, Inc.

K number K034051

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IYE 2004-02-27

ON-BOARD IMAGER DEVICE

Applicant Varian Medical Systems, Inc.

K number K040192

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IYE 2003-12-23

TRILOGY RADIOTHERAPY DELIVERY SYSTEM

Applicant Varian Medical Systems, Inc.

K number K033343

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IYE 2003-12-19

EXACTRAC GATING

Applicant Brainlab AG

K number K033287

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IYE 2003-12-15

ACCUSOFT

Applicant Direx Systems Corp.

K number K032171

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IYE 2003-12-02

XIO RADIATION TREATMENT PLANNING SYSTEM

Applicant Computerized Medical Systems, Inc.

K number K032762

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IYE 2003-11-12

MODIFICATION TO: HI-ART SYSTEM

Applicant Tomotherapy Incorporated

K number K033347

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IYE 2003-10-23

ELEKTA SYNERGY SYSTEM

Applicant Elekta Oncology Systems, Ltd.

K number K032996

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IYE 2003-10-03

MOSFET AUTOSENSE WIRELESS

Applicant Thomson & Nielsen Electronics, Ltd.

K number K032725

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IYE 2003-10-02

I-BEAM

Applicant Computerized Medical Systems, Inc.

K number K032100

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IYE 2003-09-25

PRECISE CARBON FIBER TABLE TOP, MODEL 11-999

Applicant Aktina Medical Physics Corp.

K number K032248

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IYE 2003-09-05

ONE DIMENSIONAL WATER PHANTOM, WP 1D

Applicant Wellhofer Dosimetrie

K number K032594

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IYE 2003-09-05

ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES

Applicant Siemens Medical Solutions USA, Inc.

K number K031764

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IYE 2003-09-02

ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH SHOULDER DEPRESSION, ACCUFIX RADIOLUCENT

Applicant Wfr/Aquaplast Corp.

K number K032156

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IYE 2003-08-29

IMSURE

Applicant Prodigm, Inc.

K number K031975

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IYE 2003-08-29

OMNIPRO I'MRT

Applicant Wellhofer Dosimetrie

K number K031634

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IYE 2003-07-18

STEREOTACTIC BODY FRAME, MODEL COD. 70-1A

Applicant 3D Line USA, Inc.

K number K031631

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IYE 2003-05-08

HEADFIX

Applicant Medical Intelligence Medizintechnik GmbH

K number K030439

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IYE 2003-04-17

2 BASIC

Applicant Capintec, Inc.

K number K030175

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IYE 2003-04-04

VERSABOARD, MODEL 7040

Applicant Bionix Development Corp.

K number K030051

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IYE 2003-03-11

VICTOREEN THEBES II, MODEL 7020

Applicant Syncor Radiation Management

K number K024284

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IYE 2003-01-16

RADIONICS VARILINK 2

Applicant Radionics, A Division of Tyco Healthcare Group LP

K number K023519

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IYE 2003-01-13

NON-INVASIVE PATIENT FIXATION SYSTEM

Applicant Stryker Leibinger

K number K023449

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IYE 2003-01-07

ACCULEAF

Applicant Direx Systems Corp.

K number K021338

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IYE 2002-12-23

MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02

Applicant Med-Tec,Inc.

K number K023293

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IYE 2002-11-22

BLOCKING TRAY

Applicant Southeastern Radiation Products, Inc.

K number K023636

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IYE 2002-11-12

KLARITY

Applicant Larson Products, Inc.

K number K022708

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IYE 2002-08-28

RADIOSYSTEM/NT, MODEL 80-13020

Applicant Styker Instruments

K number K020320

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IYE 2002-07-02

ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER

Applicant Wfr/Aquaplast Corp.

K number K021124

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IYE 2002-07-02

CRANIAL STEREOTACTIC EQUIPMENT

Applicant Arplay Medical S.A.

K number K010065

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IYE 2002-06-06

MODEL 1133 IVD PC VERSION

Applicant Sun Nuclear Corp.

K number K021463

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IYE 2002-06-06

M3 (MICRO-MULTILEAF COLLIMATOR)

Applicant Brainlab AG

K number K020860

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IYE 2002-04-22

MOTION TRACKING

Applicant Accuray, Inc.

K number K020294

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IYE 2002-03-26

M3 (MIRCO-MULTILEAF COLLIMATOR

Applicant Brainlab AG

K number K004022

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