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 2013-04-30

CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEM

Applicant Cdr Systems, Inc.

K number K122888

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IYE 2013-04-12

BIOMARC GOLD FIDUCIAL MARKER

Applicant Carbon Medical Technologies, Inc.

K number K130678

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IYE 2013-04-04

AGILITY

Applicant Elekta , Ltd.

K number K123808

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IYE 2013-03-01

COHERENCE RT THERAPIST CONNECT WORKSPACE, V2.3, ARIA CONNECTIVITY OPTION FOR SIEMENS NON-IMAGING SYSTEMS, ARIA CONNECTIV

Applicant Siemens Medical Solutions USA, Inc.

K number K123812

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IYE 2013-01-15

INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI)

Applicant Varian Medical Systems, Inc.

K number K123788

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IYE 2013-01-08

ALIGNRT PLUS

Applicant Vision RT Limited

K number K123371

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IYE 2012-12-21

PANTHER OIS/R & V MODEL VERSION 2.0

Applicant Prowess, Inc.

K number K122616

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IYE 2012-12-20

TRUEBEAM

Applicant Varian Medical Systems, Inc.

K number K123291

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IYE 2012-12-12

MOSAIQ ONCOLOGY INFORMATION SYSTEM

Applicant Impac Medical Systems, Inc.

K number K123230

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IYE 2012-12-05

CALYPSO SYSTEM

Applicant Varian Medical Systems

K number K123137

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IYE 2012-12-05

CLARITY

Applicant Elekta , Ltd.

K number K121663

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IYE 2012-10-26

CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM

Applicant Accuray Incorporated

K number K122137

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IYE 2012-10-23

PROTON RADIATION THERAPY BEAM-SHAPING APERTURE PROTON RADIAION THERAPY BEAM-SHPING RANGE COMPENSATOR

Applicant Proton Systems

K number K121657

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IYE 2012-10-19

SDX SYSTEM

Applicant Dyn'R Sas

K number K121845

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IYE 2012-10-03

MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS

Applicant Mitsubishi Heavy Industries, Ltd.

K number K122450

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IYE 2012-09-28

EXACTRAC VERO

Applicant Brainlab AG

K number K122451

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IYE 2012-08-29

TOMOTHERAPY TREATMENT SYSTEM

Applicant Accuray Incorporated

K number K121934

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IYE 2012-08-14

EXACTRAC X-RAY X-RAY

Applicant Brainlab AG

K number K120789

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IYE 2012-08-03

IDENTIFY

Applicant Humediq GmbH

K number K112692

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IYE 2012-07-30

SENTINEL

Applicant C-Rad Positioning AB

K number K120668

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IYE 2012-06-27

ARTISTETM SOLUTION WITH SYS VCIO

Applicant Siemens Medical Solutions USA, Inc.

K number K121295

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IYE 2012-06-20

BODYFIX SYSTEM

Applicant Medical Intelligence Medizintechnik GmbH

K number K121530

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IYE 2012-06-12

AGILITY

Applicant Elekta , Ltd.

K number K121328

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IYE 2012-05-22

VIEWRAY SYSTEM

Applicant Viewray, Incorporated

K number K111862

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IYE 2012-05-03

EMBRACE THERMOPLASTIC

Applicant Bionix Development Corp.

K number K120335

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IYE 2012-04-19

NOVAC 11

Applicant New Radiant Technology S.P.A.

K number K112286

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IYE 2012-04-17

LIAC

Applicant Sordina S.P.A.

K number K110840

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IYE 2012-03-09

SYNCHRONY RESPIRATORY TRACKING SYSTEM

Applicant Accuray Incorporated

K number K120233

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IYE 2012-02-28

MOSAIQ ONCOLOGY INFORMATION SYSTEM

Applicant Impac Medical Systems, Inc.

K number K120067

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IYE 2012-02-27

CATALYST

Applicant C-Rad Positioning AB

K number K113276

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IYE 2012-02-16

SURFACE BEACON TRANSPONDERS

Applicant Calypso Medical Technologies, Inc.

K number K112841

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IYE 2012-01-30

CLARITY OBP SYSTEM

Applicant Elekta , Ltd.

K number K111332

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IYE 2012-01-10

VOLUSON E6/E8/E8EXPERT/E10

Applicant GE Healthcare

K number K113758

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IYE 2012-01-10

TRACER IMPLANTATION KIT, INDEX IMPLANTATION KIT

Applicant Navotek Medical, Ltd.

K number K110971

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IYE 2011-12-29

SMART SEGMENTATION-KNOWLEDGE BASED CONTOURING

Applicant Varian Medical Systems

K number K112778

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IYE 2011-12-16

INTEGRITY(TM)

Applicant Elekta Limited

K number K112613

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IYE 2011-11-22

FRAXION

Applicant Medical Intelligence Medizintechnik GmbH

K number K112210

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IYE 2011-11-14

VARIAN HIGH ENERGY LINEAR ACCELERATOR

Applicant Varian Medical Systems

K number K112839

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IYE 2011-10-07

MULTIPLE

Applicant Larson Medical Products, Inc.

K number K112460

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IYE 2011-08-18

TRUEBEAM

Applicant Varian Medical Systems, Inc.

K number K111106

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IYE 2011-04-28

BIOMARC FIDUCIAL MARKER

Applicant Carbon Medical Technologies, Inc.

K number K110772

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IYE 2011-04-15

ARTISTE SOLUTION WITH SYS_VB50 UPDATE

Applicant Siemens Medical Solutions USA, Inc.

K number K103606

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IYE 2011-01-25

PINPOINT STEREOTACTIC HEAD AND NECK LOCALIZER

Applicant Aktina Medical Physics Corp.

K number K103616

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IYE 2011-01-21

REALEYE MODEL VCPS

Applicant Navotek Medical, Ltd.

K number K100625

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IYE 2011-01-12

BARCODE CONICAL COLLIMATOR VERIFICATION (BCCV)

Applicant Varian Medical Systems, Oncology Systems

K number K103394

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IYE 2010-12-27

DOSEVIEW 3D

Applicant Standard Imaging, Inc.

K number K103193

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IYE 2010-12-07

PRONEX

Applicant Direx Systems Corp.

K number K102765

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IYE 2010-11-23

PVS MODEL 1.0

Applicant Medcom GmbH

K number K102237

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IYE 2010-11-17

CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM

Applicant Accuray Incorporated

K number K102650

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IYE 2010-11-04

INTEGRITY MODEL 1014284

Applicant Elekta , Ltd.

K number K102200

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IYE 2010-11-02

MUCHECK, VERSION 9.0

Applicant Oncology Data Systems, Inc.

K number K102583

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IYE 2010-10-15

RPM RESPIRATORY GATING SYSTEM

Applicant Varian Medical Systems

K number K102024

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IYE 2010-10-12

SYNGO RT THERAPIST CONNECT WORKSPACE, V4.2

Applicant Siemens Medical Solutions USA, Inc.

K number K102671

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IYE 2010-10-01

3D SCANNER, MODEL 1230

Applicant Sun Nuclear Corp.

K number K101992

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IYE 2010-08-10

VARIAN UNIQUE SINGLE ENERGY LINEAR ACCELERATOR

Applicant Varian Medical Systems, Oncology Systems

K number K101751

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IYE 2010-08-04

DUSIMETRY CHECK

Applicant Math Resolutions, LLC

K number K101503

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IYE 2010-07-13

VARIAN HIGH ENERGY LINEAR ACCELERATOR

Applicant Varian Medical Systems

K number K100890

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IYE 2010-07-12

VARIAN TREATMENT

Applicant Varian Medical Systems, Inc.

K number K093967

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IYE 2010-06-18

PUMA MODEL VERSION 1.0

Applicant Prowess, Inc.

K number K100801

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IYE 2010-06-17

FIDUCIAL MARKERS

Applicant Cosman Medical, Inc.

K number K101131

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IYE 2010-05-11

OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500

Applicant Bionix Development Corp.

K number K100691

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IYE 2010-04-22

LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART

Applicant Integra Radionics, Inc.

K number K100096

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IYE 2010-04-09

T-FORM EXTREMITY IMMOBILIZER, MODEL RT-6060

Applicant Bionix Development Corp.

K number K100264

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IYE 2010-03-10

XVI R4.5

Applicant Elekta , Ltd.

K number K100115

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IYE 2010-03-05

P-ART, MODEL 001

Applicant P-Cure, Ltd.

K number K092424

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IYE 2010-02-24

FLEXIMARC, MODEL CM-0.9-2-10-GG-L

Applicant Cortex Manufacturing, Inc.

K number K100267

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IYE 2010-01-26

RESPISENS

Applicant Nomics

K number K092845

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IYE 2010-01-11

SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL

Applicant Dyn'R

K number K092479

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IYE 2009-12-15

ARIA RADIATION ONCOLOGY WITH MIRS

Applicant Varian Medical Systems, Inc.

K number K093527

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IYE 2009-12-15

TIGRT IVS

Applicant Linatech, LLC

K number K092550

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IYE 2009-11-30

TRILOGY MX

Applicant Varian Medical Systems, Inc.

K number K092871

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IYE 2009-10-09

PATLOG 2.0

Applicant Oncolog Medical QA AB

K number K092939

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IYE 2009-10-02

STELLAR FIDUCIAL MARKER, MODEL GFMIA

Applicant Stellar Medical, LLC

K number K092041

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IYE 2009-09-18

160MLC OPTION

Applicant Siemens Medical Solutions USA, Inc.

K number K092145

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IYE 2009-09-18

OMNIPRO INCLINE

Applicant Iba Dosimetry GmbH

K number K092018

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IYE 2009-09-18

CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM

Applicant Accuray, Inc.

K number K091999

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IYE 2009-09-15

MODEL 1014 PC ELECTROMETER

Applicant Sun Nuclear Corp.

K number K092019

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IYE 2009-08-28

PORTABLE DOSIMETER DOSE VERIFICATION SYSTEM, MODEL TD-RD-90

Applicant Best Medical Canada , Ltd.

K number K092285

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IYE 2009-07-21

GOLD ANCHOR

Applicant Naslund Medical AB

K number K091645

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IYE 2009-07-07

TIGRT MLC, TIGRT DMLC

Applicant Linatech, LLC

K number K090802

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IYE 2009-06-23

PORTALVISION ADVANCED IMAGING

Applicant Varian Medical Systems, Inc.

K number K091209

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IYE 2009-06-18

MUCHECK V8

Applicant Oncology Data Systems, Inc.

K number K091602

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IYE 2009-06-17

4D INTEGRATED TREATMENT CONSOLE

Applicant Varian Medical Systems

K number K091132

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IYE 2009-05-08

SYNGO RT THERAPIST CONNECT

Applicant Siemens Medical Solutions USA, Inc.

K number K090683

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IYE 2009-03-30

SENTINEL, MODEL SP-001

Applicant C-Rad Positioning AB

K number K082582

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IYE 2009-03-09

CLEARVUE PRONE BREAST TREATMENT TABLE

Applicant Orbital Therapy, LLC

K number K090349

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IYE 2009-02-19

PRESCISION OPTION

Applicant Siemens Medical Solutions USA, Inc.

K number K082775

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IYE 2009-01-22

PATLOG, PATLOG PATIENT HANDLING SYSTEM, PATLOG TOPLOG TABLE TOP, MODEL(S) 1.0, 1.0, C

Applicant Oncolog Medical QA AB

K number K090044

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IYE 2008-12-23

RSVP HALF SPHERE PHANTOM, MODEL DDP010

Applicant The Phantom Laboratory, Inc.

K number K082909

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IYE 2008-11-19

STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331

Applicant Standard Imaging, Inc.

K number K082773

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IYE 2008-10-07

STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100

Applicant Aktina Medical Physics Corp.

K number K081935

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IYE 2008-08-29

MLCI2

Applicant Elekta , Ltd.

K number K082122

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IYE 2008-08-04

MODIFICATION TO ONEDOSE PATIENT DOSIMETRY SYSTEM

Applicant Sicel Technologies, Inc.

K number K081859

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IYE 2008-07-29

RSVP PHANTOM PELVIS, MODEL TLP260

Applicant The Phantom Laboratory, Inc.

K number K081760

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IYE 2008-07-21

BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST

Applicant It-V Medizintechnik, GmbH

K number K081218

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IYE 2008-07-14

TRILOGY WITH EXTERNAL SYSTEM GATING INTERFACE

Applicant Varian Medical Systems, Inc.

K number K081188

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IYE 2008-06-11

DESKTOP PRO

Applicant Elekta , Ltd.

K number K080585

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IYE 2008-06-04

MRI PATIENT POSITIONING DEVICES

Applicant CIVCO Medical Instruments Co., Inc.

K number K080072

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IYE 2008-05-14

CALYPSO 4D LOCALIZATION SYSTEM

Applicant Calypso Medical Technologies, Inc.

K number K080726

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IYE 2008-05-09

4D INTEGRATED TREATMENT CONSOLE WITH PATIENT ACCESSORY VERIFICATION SYSTEM (PAVS)

Applicant Varian Medical Systems, Inc.

K number K081036

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