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 1993-11-15

VICTOREEN MODEL 530

Applicant Victoreen, Inc.

K number K931927

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IYE 1993-11-03

RADASSIST

Applicant Diacor, Inc.

K number K934566

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IYE 1993-11-03

RAM-PACS

Applicant Medical Knowledge Systems, Inc.

K number K933493

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IYE 1993-10-07

PITUITARY BOARD

Applicant Bionix Development Corp.

K number K933614

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IYE 1993-10-07

3-WAY HEAD IMMOBILIZER; 3WAY DELUXE REUSABLE FRAME HEAD IMMOBILIZER

Applicant Bionix Development Corp.

K number K933613

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IYE 1993-08-18

LINAC-BASED STEROTACTIC RADIOSURGERY

Applicant Radionics Software Applications, Inc.

K number K923522

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IYE 1993-07-27

REFIX(TM) SYSTEM

Applicant Nomos Corp.

K number K930279

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IYE 1993-07-26

MAMMORX

Applicant Diacor, Inc.

K number K930246

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IYE 1993-06-08

BREAST SIMULATION SYSTEM

Applicant Severn Research, Inc.

K number K925714

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IYE 1993-06-08

PHILIPS RTNET RADIOTHERAPY NETWORKING SYSTEM

Applicant Philips Medical Systems, Inc.

K number K924495

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IYE 1993-05-17

PROWESS 2000

Applicant Small Systems Group, Inc.

K number K924240

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IYE 1993-04-07

LCM-2-LINAC COUCH-MOUNT SYSTEM

Applicant Radionics, Inc.

K number K924632

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IYE 1993-04-07

COMPUTER ASSISTED STEREOTACTIC SURGERY -- MODIFIED

Applicant Medical Instrumentation & Diagnostics Corp.(Midco)

K number K921740

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IYE 1992-12-29

BRAINSCAN RADIOSURGERY MODULE

Applicant Brainlab

K number K920879

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IYE 1992-11-27

PLATO RADIATION THERAPY PLANNING SYSTEM

Applicant Nucletron-Oldelft Corp.

K number K921991

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IYE 1992-10-15

LINEAR ACCELERATOR COLLIMATOR

Applicant Medical Equipment Development Co., Inc.

K number K911973

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IYE 1992-06-05

SETUP COMPUTER WITH SOFTWARE V-1261,62 AND 63

Applicant K.S., Inc.

K number K914698

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IYE 1992-03-31

THERAVIEW DIGITAL PORTAL IMAGING COMPUTER (MOD.)

Applicant S & S Inficon, Inc.

K number K920455

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IYE 1992-03-30

ADAC XL-PLAN-PC

Applicant Adac Laboratories

K number K920041

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IYE 1991-12-19

SEQUENCER

Applicant Impac Medical Systems, Inc.

K number K913612

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IYE 1991-11-22

RECORD AND VERIFY MEVATRON ADAPTER

Applicant Computerized Medical Systems, Inc.

K number K913674

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IYE 1991-11-07

VARIAN C-SERIES CLINACS (CLINAC 2300C/D)

Applicant Varian Assoc., Inc.

K number K913119

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IYE 1991-11-05

VARIAN CLINAC 600SR

Applicant Varian Assoc., Inc.

K number K913174

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IYE 1991-11-04

XKNIFE RADIOSURGERY SYSTEM

Applicant Rsa, Inc.

K number K912630

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IYE 1991-10-15

COMPUTER ASSIST STEREOTACTIC SURG SYST, MODIFIED

Applicant Medical Instrumentation & Diagnostics Corp.(Midco)

K number K911750

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IYE 1991-06-13

NUCLETRON PLANNING SYSTEM

Applicant Nucletron-Oldelft Corp.

K number K911612

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IYE 1991-06-06

STEREOTACTIC IRRADIATION SYSTEM

Applicant Northwest Medical Physics Center

K number K904908

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IYE 1991-05-03

VARIAN ELECTRONIC PORTAL IMAGING SYSTEM

Applicant Varian Assoc., Inc.

K number K901932

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IYE 1991-02-27

VARIAN C-SERIES CLINACS CLINAC 600C,2100C,2500C

Applicant Varian Assoc., Inc.

K number K904364

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IYE 1991-02-12

STANDARD BREAST BOARDS; DELUXE BREAST BOARD

Applicant Bionix Development Corp.

K number K905007

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IYE 1990-11-07

BEAMVIEW & BEAMVIEW PLUS (AKA PROJECT 743)

Applicant Siemens Medical Laboratories, Inc.

K number K903139

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IYE 1990-10-23

MM-22 MICROTRON, MM50 MICROTRON

Applicant Scanditronix, Inc.

K number K900434

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IYE 1990-08-23

THERAVIEW DIGITAL PORTAL IMAGING COMPUTER

Applicant S & S Inficon, Inc.

K number K902339

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IYE 1990-08-03

PHILIPS VERIFLEX

Applicant Philips Medical Systems, Inc.

K number K902849

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IYE 1990-03-23

STP COMPLETE MODULE SET

Applicant Leibinger & Fischer , Ltd.

K number K892425

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IYE 1990-01-12

VAC FIX(R) SYSTEM

Applicant S&S Par Scientific

K number K895697

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IYE 1990-01-03

RENNER-PLAN

Applicant W.D. Renner Consulting Co.

K number K894722

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IYE 1989-11-21

FIBERVISION(TM)

Applicant Fiber Imaging, Inc.

K number K895733

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IYE 1989-11-06

PATIENT POSITIONING ACCESSORIES

Applicant Perkins Mfg. Co.

K number K895500

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IYE 1989-10-13

SRI 100 RADIOTHERAPY IMAGING SYSTEM

Applicant Philips Medical Systems, Inc.

K number K894912

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IYE 1989-10-11

HT-RES RTP SYSTEM

Applicant Adac Laboratories

K number K894706

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IYE 1989-09-18

SRS-200 RADIOSURGERY SYSTEM

Applicant Philips Medical Systems North America, Inc.

K number K891292

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IYE 1989-09-01

MEDISYS RECORD AND VERIFY SYSTEM

Applicant Medisys, Inc.

K number K893978

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IYE 1989-08-28

PATIENT DATA MANAGEMENT SYSTEM (PROJECT 735)

Applicant Siemens Medical Laboratories, Inc.

K number K894230

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IYE 1989-08-28

VERICORD S3

Applicant Philips Medical Systems, Inc.

K number K894123

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IYE 1989-07-20

SOFTWARE RELEASE 1.3 FOR THE SL SERIES LINEAR ACCE

Applicant Philips Medical Systems, Inc.

K number K892845

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IYE 1989-06-23

SATURNE 41

Applicant General Electric Co.

K number K892860

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IYE 1988-11-10

SATURNE 42 AND 43

Applicant General Electric Co.

K number K883019

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IYE 1988-10-11

SL SERIES ACCELERATORS SL15, SL18, SL20 & SL25

Applicant Philips Medical Systems, Inc.

K number K883264

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IYE 1988-10-07

DVS (OPTION 01)

Applicant O.M.I. Oncology Microsystems, Inc.

K number K883101

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IYE 1988-09-30

MODIFIED SL-SERIES LINEAR ACCELERATORS

Applicant Philips Medical Systems, Inc.

K number K883067

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IYE 1988-09-22

SL SERIES, SL 15, 18, 20 & 25 (MODIFICATION)

Applicant Philips Medical Systems, Inc.

K number K882231

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IYE 1988-09-19

MEVATRON, M 2 CLASS

Applicant Siemens Medical Laboratories, Inc.

K number K882729

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IYE 1988-09-19

VARIAN CLINAC 1800S

Applicant Varian Assoc., Inc.

K number K882326

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IYE 1988-08-04

EXL-14 MEDICAL LINEAR ACCELERATOR

Applicant Mitsubishi Intl. Corp.

K number K880200

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IYE 1988-05-02

SL SERIES, SL 15, 18, 20 & 25

Applicant Philips Medical Systems, Inc.

K number K874558

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IYE 1988-04-29

EXL-22DP X-RAY RADIATION THERAPY SYSTEM

Applicant Mitsubishi Intl. Corp.

K number K873398

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IYE 1988-02-17

MODEL 35300 TRACKER(TM) THERAPY BEAM EVALUATOR

Applicant Keithley Instruments, Inc.

K number K874893

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IYE 1987-05-08

GRATICULE

Applicant Mick Radio-Nuclear Instruments, Inc.

K number K871214

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IYE 1987-04-01

PHILIPS MODEL SL75-10 LINEAR ACCELERATOR

Applicant Industrial Accelerator Co.

K number K870525

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IYE 1987-03-16

MEVACHECK

Applicant Magus Microcontrollers, Inc.

K number K864910

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IYE 1987-01-06

COMPUTER CONTROLLED EXTENSION (CCX)

Applicant Varian Assoc., Inc.

K number K863705

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IYE 1986-10-29

MEVATRON KD-2

Applicant Siemens Medical Laboratories, Inc.

K number K862339

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IYE 1986-10-03

CLINAC (R) C SERIES (400C, 600C, 2100C, 2500C)

Applicant Varian Assoc., Inc.

K number K862645

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IYE 1986-09-19

VARIAN RMS-2000

Applicant Varian Assoc., Inc.

K number K863358

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IYE 1986-08-26

PC-PLAN

Applicant Dosimetrix, Inc.

K number K862065

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IYE 1986-02-06

MEVASSIST(SETUP CONTROLLER)

Applicant Magus Microcontrollers, Inc.

K number K852609

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IYE 1985-07-18

ADAC MODELS XL-PLAN 23 & XL-PLAN 73

Applicant Adac Laboratories

K number K851041

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IYE 1984-03-16

LINEAR ACCELERATOR MULTIPLE EXL 3-4-6

Applicant Adac Laboratories

K number K840136

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IYE 1983-12-29

ORION

Applicant Cgr Medical Corp.

K number K833941

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IYE 1983-09-29

RADIOTHERAPY MGMT. SYSTEM RMS-1000

Applicant Varian Assoc., Inc.

K number K832732

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IYE 1983-09-12

CLINAC 1800

Applicant Varian Assoc., Inc.

K number K832503

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IYE 1983-09-12

ELECTRON BEAM OPTION FOR CLINAC 15 MEV

Applicant Varian Assoc., Inc.

K number K832502

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IYE 1983-09-12

VARIAN CLINACOMP 100 TISSUE COMPENSATOR

Applicant Varian Assoc., Inc.

K number K832216

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IYE 1983-06-24

LINEAR ACCELERATOR THERAC 25

Applicant Atomic Energy of Canada

K number K837347

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IYE 1982-03-31

ARS-1000

Applicant Applied Radiation

K number K820448

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IYE 1982-03-31

DELTA PLAN II RADIATION THERAPY PLAN

Applicant Technicare Corp.

K number K820310

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IYE 1981-08-18

MEVATRON 67E

Applicant Siemens Medical Laboratories, Inc.

K number K812032

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IYE 1981-01-07

ELECTRON ARC THERAPY

Applicant Varian Assoc., Inc.

K number K802809

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IYE 1981-01-07

6MV PORT FILM CAPABILITY OPTION

Applicant Varian Assoc., Inc.

K number K802808

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IYE 1980-05-14

ADJUSTABLE HEAD & FACE HOLDER

Applicant Radiation Products Design, Inc.

K number K800792

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IYE 1980-05-14

MYLAR WINDOW-TABLE INSERT PANEL

Applicant Radiation Products Design, Inc.

K number K800791

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IYE 1980-05-14

TENNIS RACKET-TABLE INSERT PANEL

Applicant Radiation Products Design, Inc.

K number K800790

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IYE 1980-05-14

POINT TO POINT LEVEL

Applicant Radiation Products Design, Inc.

K number K800761

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IYE 1980-05-14

ELEV. BACK SUPPORT W/ADJ. ARM POSITIONER

Applicant Radiation Products Design, Inc.

K number K800759

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IYE 1979-11-16

MEVATRON 74X MEDICAL LINEAR ACCELERATOR

Applicant Siemens Medical Laboratories, Inc.

K number K791967

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IYE 1979-05-04

MEVATRON 74

Applicant Siemens Medical Laboratories, Inc.

K number K790747

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IYE 1979-04-23

MEVATRON 67

Applicant Siemens Medical Laboratories, Inc.

K number K790688

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IYE 1979-03-26

MEVATRON 60

Applicant Siemens Medical Laboratories, Inc.

K number K790388

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IYE 1978-11-27

CLINAC 2500

Applicant Varian Assoc., Inc.

K number K781872

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IYE 1978-09-14

CLINAC 12/10

Applicant Varian Assoc., Inc.

K number K781174

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IYE 1978-07-17

CLINAC 20 (OPTIONAL 18 MV VERSION)

Applicant Varian Assoc., Inc.

K number K781057

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IYE 1978-01-26

ACCELERATOR, LINEAR, MED.

Applicant Emi Therapy Systems, Inc.

K number K780027

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IYE 1977-10-19

EMI FOUR

Applicant Emi Therapy Systems, Inc.

K number K771902

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IYE 1977-10-19

CLINAC 6/100

Applicant Varian Assoc., Inc.

K number K771809

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IYE 1977-10-19

CLINAC 4/100

Applicant Varian Assoc., Inc.

K number K771808

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IYE 1977-08-16

CLINAC 20

Applicant Varian Assoc., Inc.

K number K771358

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IYE 1977-08-03

LINEAR ACCELERATOR G-2900

Applicant Atomic Energy of Canada

K number K771260

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