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 2002-03-05

AKTINA MEDICAL PHYSICS RADIATION THERAPY WEDGES

Applicant Aktina Medical Physics Corp.

K number K014081

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IYE 2002-03-04

MRI LINE MARKER

Applicant I.Z.I. Corp.

K number K014022

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IYE 2002-01-11

BODYFIX

Applicant Medical Intelligence Medizintechnik GmbH

K number K013391

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IYE 2001-12-04

MILLCOMP

Applicant Math Resolutions, LLC

K number K011845

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IYE 2001-10-18

MOSFET AUTOSENSE, MODEL TN-RD-60

Applicant Thomson & Nielsen Electronics, Ltd.

K number K013279

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IYE 2001-10-01

MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1

Applicant Oncology Data Systems, Inc.

K number K012227

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IYE 2001-09-21

INTRA OPERATIVE RADIATION THERAPY

Applicant Arplay Medical S.A.

K number K004023

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IYE 2001-09-05

OMNIDOS

Applicant Scanditronix Medical AB

K number K011763

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IYE 2001-08-14

MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID)

Applicant Elekta Oncology Systems, Ltd.

K number K012289

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IYE 2001-08-10

CYBERKNIFE SYSTEM

Applicant Accuray, Inc.

K number K011024

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IYE 2001-07-31

EXAC TRAC 2.0 (NOVALIS BODY MODULE)

Applicant Brainlab AG

K number K003285

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IYE 2001-07-26

RF-IVD WIRELESS DOSIMETER-MODEL 1133

Applicant Sun Nuclear Corp.

K number K011332

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IYE 2001-07-12

IMMOBILIZATION SYSTEM FOR ENT

Applicant Arplay Medical S.A.

K number K003779

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IYE 2001-06-20

PTW DOSIMETRY DIODE, T60008

Applicant Ptw-New York Corp.

K number K010916

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IYE 2001-06-08

BREAST-BOARD (MULTIPLE)

Applicant Arplay Medical S.A.

K number K003778

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IYE 2001-05-17

RADCALC, MODEL V.4.0

Applicant Lifeline Software, Inc.

K number K010464

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IYE 2001-05-08

PATIENT DOSE VERIFICATION SYSTEM, MODEL TN-RD-50

Applicant Thomson & Nielsen Electronics, Ltd.

K number K010472

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IYE 2001-05-04

IVD (IN VIVO DOSIMETER), MODEL 1131

Applicant Sun Nuclear Corp.

K number K010449

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IYE 2001-05-02

ECLIPSE 6.5

Applicant Varian Medical Systems, Inc.

K number K010975

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IYE 2001-04-24

DOSIMETRY CHECK

Applicant Math Resolutions, LLC

K number K010225

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IYE 2001-04-18

TRAY ADAPTERS, MULTIPLE

Applicant Arplay Medical S.A.

K number K010174

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IYE 2001-04-02

COUCH FOR TOTAL BODY RADIATION

Applicant Arplay Medical S.A.

K number K010063

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IYE 2001-03-13

STYROFOAM CUTTERS FOR BLOCK CASTING SYSTEM

Applicant Arplay Medical S.A.

K number K010062

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IYE 2001-03-13

BEAM BLOCK TRAYS

Applicant Arplay Medical S.A.

K number K004015

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IYE 2001-02-02

PORTALVISION

Applicant Varian Medical Systems, Inc.

K number K003636

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IYE 2001-01-04

AKTINA MEDICAL PHYSICS CORPORATION ACTIVE BREATHING COORDINATOR (ABC)

Applicant Aktina Medical Physics Corp.

K number K003330

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IYE 2000-11-16

INVAC

Applicant Duncan Hynd Associates, Ltd.

K number K002608

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IYE 2000-10-20

RADIOCAMERAS EXTRACRANIAL SYSTEM

Applicant Surgical Navigation Technologies, Inc.

K number K000246

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IYE 2000-10-18

PRECISION DOSIMETRY ELECTROMETER, MODEL 1010 OR 206

Applicant Sun Nuclear Corp.

K number K002444

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IYE 2000-09-28

PREFERENCE TREATMENT SYSTEM

Applicant Northwest Medical Physics Equipment, Inc.

K number K001833

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IYE 2000-09-05

INVIDOS

Applicant Scanditronix Medical AB

K number K002051

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IYE 2000-08-30

MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX

Applicant Med-Tec,Inc.

K number K001052

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IYE 2000-08-18

DOSE 1

Applicant Scanditronix Wellhofer North America

K number K000209

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IYE 2000-06-23

VARIS 1.4G

Applicant Varian Medical Systems, Inc.

K number K001643

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IYE 2000-06-22

NOVAC7

Applicant Hitesys S.P.A.

K number K990209

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IYE 2000-03-27

MLC FIT

Applicant Impac Medical Systems, Inc.

K number K991133

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IYE 2000-03-22

RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION

Applicant Surgical Navigation Technologies, Inc.

K number K994355

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IYE 2000-02-14

PERMA-DOC PHANTOM

Applicant Mick Radio-Nuclear Instruments, Inc.

K number K993960

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IYE 2000-02-14

ISOCENTRIC BEAM CHECKER

Applicant Mick Radio-Nuclear Instruments, Inc.

K number K993959

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IYE 2000-02-10

MU PLUS

Applicant Rad Therapy Solutions, Inc.

K number K992689

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IYE 2000-02-02

SUPER TISSUE

Applicant I.Z.I. Corp.

K number K993742

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IYE 1999-12-21

RAPTOR TREATMENT PLANNING SYSTEM

Applicant Nomos Corp.

K number K993359

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IYE 1999-12-15

CONFORMAX MMLC VR1

Applicant Radionics, Inc.

K number K993594

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IYE 1999-11-26

PRIMUS

Applicant Siemens Medical Solutions USA, Inc.

K number K993425

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IYE 1999-09-21

RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS

Applicant Orfit Industries

K number K991319

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IYE 1999-09-03

THE NOMOS CHANE II

Applicant Nomos Corp.

K number K991966

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IYE 1999-07-30

AKTINA MEDICAL PHYSICS CORPORATION TILT BOARD

Applicant Aktina Medical Physics Corp.

K number K991546

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IYE 1999-07-30

TLC PEDIATRIC FRAME, MODEL TLC-SYS

Applicant Radionics, Inc.

K number K991523

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IYE 1999-07-12

BODYLOC WHOLE BODY STEREOTACTIC LOCALIZER SYSTEM FOR RADIOTHERAPY

Applicant Medical Instrumentation & Diagnostics Corp.(Midco)

K number K991336

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IYE 1999-06-29

SHADOW TRAYS

Applicant Mick Radio-Nuclear Instruments, Inc.

K number K991107

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IYE 1999-06-22

AKTINA MEDICALPHYSICS CORPORATION MECHANICAL FRONTPOINTER

Applicant Aktina Medical Physics Corp.

K number K990997

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IYE 1999-06-08

DOSE CALC, MODEL VS. 1.02

Applicant Integrity Medical Software, Inc.

K number K990833

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IYE 1999-05-28

DPD-12PCC

Applicant Scanditronix Medical AB

K number K990734

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IYE 1999-05-12

ROCS ULTRASEED

Applicant Radiation Oncology Computer Systems

K number K984241

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IYE 1999-05-05

APOLLO 5, APOLLO 10

Applicant Precitron A.B.

K number K990383

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IYE 1999-04-02

FOCUS PILOT CONTOURING WORKSTATION

Applicant Computerized Medical Systems, Inc.

K number K981535

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IYE 1999-03-17

OSIRIS

Applicant Huestis Medical

K number K981153

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IYE 1999-02-08

MILLENNIUM MLC -120

Applicant Varian Assoc., Inc.

K number K990085

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IYE 1998-12-30

RADIONICS MINI MULTI-LEAF COLLIMATOR, MODEL RADIONICS MMLC

Applicant Radionics, Inc.

K number K982549

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IYE 1998-11-12

PROFA

Applicant Duncan Hynd Associates, Ltd.

K number K981911

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IYE 1998-11-02

RT DESKTOP

Applicant Elekta Oncology Systems, Ltd.

K number K982713

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IYE 1998-10-26

MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242

Applicant Med-Tec,Inc.

K number K982624

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IYE 1998-10-09

RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITY

Applicant Radionics, Inc.

K number K981597

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IYE 1998-09-30

EXTRACRANIAL RADIOTHERAPY SYSTEM

Applicant Howmedica, Inc.

K number K982463

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IYE 1998-09-29

XKNIFE-4

Applicant Radionics, Inc.

K number K981055

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IYE 1998-08-07

IVIEW ELECTRONIC PORTAL IMAGING DEVICE (EPID) MODEL NUMBER IVEW

Applicant Elekta Oncology Systems, Ltd.

K number K981790

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IYE 1998-07-31

MX MEVATRON

Applicant Siemens Medical Solutions USA, Inc.

K number K982513

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IYE 1998-07-31

GENESIS IMRT LINEAR ACCELERATOR

Applicant Siemens Medical Solutions USA, Inc.

K number K982502

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IYE 1998-07-17

NOMOS BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM

Applicant Nomos Corp.

K number K981424

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IYE 1998-07-10

RADIOCAMERAS BITEBLOCK LOCALIZATION AND POSITIONING SYSTEM

Applicant Surgical Navigation Technologies, Inc.

K number K981346

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IYE 1998-07-09

SEQUENCER

Applicant Impac Medical Systems, Inc.

K number K981313

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IYE 1998-06-08

MUCHECK MONITOR UNIT VALIDATION PROGRAM

Applicant Medical Dosimetry Services, Inc.

K number K980904

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IYE 1998-06-01

EQUIDOSE SOLID STATE DIODE DETECTORS

Applicant Cii Mastek, Inc.

K number K980826

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IYE 1998-06-01

FOCUS RTP SYSTEM

Applicant Computerized Medical Systems, Inc.

K number K973936

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IYE 1998-05-20

RADIOCAMERAS PATIENT POSITIONING SYSTEM

Applicant Surgical Navigation Technologies, Inc.

K number K980750

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IYE 1998-05-18

PROWESS PRO-SIM

Applicant Ssgi Prowess Systems

K number K980379

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IYE 1998-05-06

VSS, VIRTUAL SIMULATION SYSTEM

Applicant Nucletron Corp.

K number K980629

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IYE 1998-04-24

CAPINTEC MODEL 292 ELECTROMETER

Applicant Capintec, Inc.

K number K980402

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IYE 1998-03-10

CARBON FIBER BREAST BOARD

Applicant Medtec, Inc.

K number K974703

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IYE 1998-03-04

MATRIX MT-MX3

Applicant Medtec, Inc.

K number K974700

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IYE 1998-02-06

NOMOS SLIT COLLIMATOR (BEAK)

Applicant Nomos Corp.

K number K974310

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IYE 1998-01-23

ADVANCED TREATMENT PLANNING SYSTEM

Applicant Advanced Radiation Therapy Systems, Inc.

K number K972816

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IYE 1998-01-22

COREGISTRATION FUNCTION

Applicant Nomos Corp.

K number K972451

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IYE 1998-01-14

120 LEAF MULTILEAF COLLIMATOR

Applicant Mitsubishi Electronics America, Inc.

K number K973963

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IYE 1997-12-17

ELEKTA ONCOLOGY SYSTEMS ICOM/QUICKMODE SOFTWARE OPTIONS

Applicant Elekta Oncology Systems, Inc.

K number K973540

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IYE 1997-11-21

VARIAN MULTILEAF COLLIMATOR WITH DYNAMIC ARC THERAPY FEATURE

Applicant Varian Medical Systems, Inc.

K number K973889

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IYE 1997-11-13

SNT LINAC ACCESSORIES

Applicant Surgical Navigation Technologies, Inc.

K number K971893

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IYE 1997-10-28

XPLAN-1

Applicant Radionics Software Applications, Inc.

K number K972905

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IYE 1997-10-27

BRAINSCAN CONFORMAL RT MODULE

Applicant Brainlab AG

K number K971367

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IYE 1997-10-23

BANG POLYMER GEL DOSIMETER, BANG 533

Applicant Mgs Research, Inc.

K number K972804

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IYE 1997-10-16

TBI STAND

Applicant Mick Radio-Nuclear Instruments, Inc.

K number K972709

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IYE 1997-10-01

HELAX-VISIR

Applicant Helax AB

K number K972617

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IYE 1997-09-08

LANTIS TREATSTATION

Applicant Siemens Medical Solutions USA, Inc.

K number K972275

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IYE 1997-09-05

P REFERENCE TPS (TREATMENT PLANNING SOFTWARE) 1.1

Applicant Northwest Medical Physics Equipment, Inc.

K number K970464

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IYE 1997-08-05

ANTI-TUMOR EXPERT SYSTEM (ATES) FOR RADIATION THERAPY TREATMENT PLANNING

Applicant Topslane

K number K963451

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IYE 1997-07-29

VELOS CONSTANCY CHECK DEVICE, MODEL 55-145

Applicant Aktina Medical Physics Corp.

K number K970384

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IYE 1997-07-23

TARGET 2 VERSION 1.1

Applicant GE Medical Systems

K number K965010

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IYE 1997-07-22

CADPLAN, VERSION 2.62. RADIATION THERAPY TREATMENT PLANNING SYSTEM

Applicant Varian Medical Systems, Inc.

K number K962950

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IYE 1997-07-09

THERAPLAN PLUS VERSION 1.2

Applicant Theratronics, Inc.

K number K970236

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IYE 1997-06-20

NUCLETRON PLATO EXTERNAL BEAM PLANNING RTS V2 AND RTS 3D V2

Applicant Nucletron Corp.

K number K964206

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