System, X-Ray, Fluoroscopic, Image-Intensified

FDA product code JAA · 291 cleared devices

Class 2 Radiology

Regulation: 21 CFR 892.1650
Review panel: RA
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-12-29 – 2026-05-29

JAA 1989-09-18

DA-100HS

Applicant Fischer Imaging Corp.

K number K894913

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JAA 1989-08-10

UROVIEW II

Applicant Oec-Diasonics, Inc.

K number K893475

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JAA 1989-08-09

PK2025/PK2045 PROGRAMMABLE VIDEO CONTROLLER

Applicant Perkins Mfg. Co.

K number K893644

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JAA 1989-06-23

ANGIOTEC SPX SPLIT SCREEN DUAL CHANNEL SCAN CONV.

Applicant Andros Analyzers, Inc.

K number K893476

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JAA 1989-06-06

DIGITAL SPOT IMAGING (DSI)

Applicant Philips Medical Systems, Inc.

K number K893131

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JAA 1989-04-20

SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-1200

Applicant Shimadzu Precision Instruments, Inc.

K number K884598

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JAA 1989-03-15

MULTI CAMERA CONTROL UNIT (MCCU)

Applicant Leybold-Inficon, Inc.

K number K884028

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JAA 1989-03-14

PHOTOMULITPLIER TUBE INTERFACE P.C. BOARD

Applicant U.S. Imaging, Inc.

K number K890878

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JAA 1989-03-14

SC-1000 WITH SUFFIXES (SCAN CONVERTER)

Applicant Eigen

K number K890745

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JAA 1989-02-09

POLARIX 2 AND POLARIX 2E

Applicant Dyna-Med

K number K884578

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JAA 1989-01-09

UNIVERSAL ABC CONTROLER

Applicant Philips Medical Systems (Cleveland), Inc.

K number K883580

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JAA 1988-12-20

MEDRAD FLUOROSCOPIC VIDEO ENHANCEMENT SYSTEM

Applicant Medrad, Inc.

K number K884317

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JAA 1988-11-25

ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT

Applicant Ausonics Pty , Ltd.

K number K883372

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JAA 1988-11-21

CARDIAC CX

Applicant Fischer Imaging Corp.

K number K883985

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JAA 1988-10-21

HIMOBILIX 2N

Applicant Bay X-Ray, Inc.

K number K883161

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JAA 1988-09-14

SHIMADZU LATERAL C-ARM MH-31

Applicant Shimadzu Precision Instruments, Inc.

K number K882311

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JAA 1988-08-19

HR-2000 W/SUFFIXES B,C,D, CARDIO & DIGI LOOP, DDVP

Applicant Eigen

K number K882175

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JAA 1988-08-11

VTR-12

Applicant Eigen

K number K882176

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JAA 1988-02-29

CEILING MOUNTED FLUOROSCOPIC C-ARM ARIEL C-ARM

Applicant Fischer Imaging Corp.

K number K880527

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JAA 1988-02-26

P2020 MOBILE C-ARM IMAGE INTENSIFIER

Applicant Photo Medic Equipment, Inc.

K number K874905

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JAA 1988-01-29

REVELATION, RADIO FLUOROSCOPIC X-RAY EXAM TABLE

Applicant Fischer Imaging Corp.

K number K874901

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JAA 1988-01-19

SHIMADZU CATHETERIZATION C-ARM STAND MH-50A

Applicant Shimadzu Precision Instruments, Inc.

K number K875157

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JAA 1988-01-19

FLUORO COVER

Applicant Condor Medical

K number K873985

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JAA 1987-06-22

LP LATERAL FLUORO POSITIONER (B5077A)

Applicant General Electric Co.

K number K872061

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JAA 1987-06-22

VIDEO PLUS MODELS VP500, VP500A AND VP1000

Applicant Camtronics, Ltd.

K number K871743

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JAA 1987-05-29

THE F SPOON HAND HELD FLUOROSCOPIC COMPRESSION

Applicant F. Spoon Co.

K number K871911

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JAA 1987-05-01

DTV-4112 FLUOROSCOPIC TELEVISION CAMERA

Applicant Adac Laboratories

K number K871127

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JAA 1987-05-01

DTV-411OP

Applicant Adac Laboratories

K number K870869

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JAA 1987-03-31

CANON X-RAY IMAGE DISTRIBUTOR CXI-3-3D

Applicant Canon USA, Inc.

K number K871119

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JAA 1987-03-06

EAZY COVERS

Applicant Superior Medical Products

K number K863853

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JAA 1987-02-11

EUSEK-BUSH IN-BATH FILMING DEVICE (#MC-00186)

Applicant The Mason Clinic

K number K870429

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JAA 1987-02-10

TELAMAT

Applicant Comet Ltd. C/O Radiology Resources, Inc.

K number K864749

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JAA 1987-01-30

MODIFIED MAINFRAME OF MODEL 902 MOBILE C-ARM

Applicant Oec-Diasonics, Inc.

K number K864837

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JAA 1986-12-29

FLUOROVISION CONTRAST ENHANCER

Applicant Digivision, Inc.

K number K864584

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JAA 1986-06-16

SCX SYSTEM

Applicant General Electric Co.

K number K862120

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JAA 1986-06-13

FLUOROSCOPE BAND BAG

Applicant Medi-Plast Intl., Inc.

K number K861785

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JAA 1986-04-22

DIAMED MODELS 600, 900, 960, 964

Applicant Diamed Division Ill. Tool Works, Inc.

K number K854953

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JAA 1986-03-10

XISCAN MODEL 1000

Applicant Xi Tech

K number K852346

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JAA 1986-01-10

PET-SCOPE II IMAGE INTENSIFIER

Applicant Philips Medical Systems (Cleveland), Inc.

K number K855213

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JAA 1985-10-16

CANON X-RAY IMAGE DISTRIBUTOR

Applicant Canon USA, Inc.

K number K853984

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JAA 1985-05-28

EXPOSCOP MOBILE IMAGING SYSTEM

Applicant Euro-Electronics, Inc.

K number K851031

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JAA 1985-04-09

EQUIPMENT SNAP KOVERS

Applicant Advance Medical Designs, Inc.

K number K850959

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JAA 1985-03-26

EIGEN FLORO-STOR FS-100

Applicant Eigen Video

K number K844375

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JAA 1985-02-07

FLUOROSCAN/TM BY HEALTHMATE

Applicant Healthmate, Inc.

K number K843920

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JAA 1985-01-03

ANGIOPLUS-S

Applicant Oec-Diasonics, Inc.

K number K843972

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JAA 1985-01-03

FLUOROSCOPIC AUTOMATIC BRIGHTNESS CNTL

Applicant Afp Imaging Corp.

K number K843917

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JAA 1984-11-08

STENOSCOP

Applicant Cgr Medical Corp.

K number K843235

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JAA 1984-11-08

IDAS DIGITAL FLUOROSCOPIC IMAGINS SYS

Applicant Micro Consultants, Inc.

K number K842217

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JAA 1984-10-25

DIGISTORE 50

Applicant Vas Corp.

K number K842191

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JAA 1984-06-05

FLUOROSCOPIC IMAGE INTENSIFIER

Applicant Phoenix Radiology, Ltd.

K number K840621

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JAA 1984-03-22

C-ARM CEILING CRANE FT-2

Applicant Medicor USA , Ltd.

K number K840225

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JAA 1984-03-19

REGISTREX 1000 PLUS DIGITAL RADIOGRAPHY

Applicant Advanced Technology Laboratories, Inc.

K number K840364

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JAA 1984-03-16

DIGITAL FLUOROGRAPHY X-RAY SYSTEM

Applicant Adac Laboratories

K number K840191

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JAA 1984-03-16

CAMTEX 1000

Applicant Digital Imaging Co. of America

K number K840134

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JAA 1984-02-21

TECHNICARE MODEL 1047

Applicant Technicare Corp.

K number K840390

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JAA 1984-01-10

DIGITAL RADIOGRAPHY SYS-DPS7100

Applicant Adac Laboratories

K number K834287

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JAA 1984-01-04

BI-PLANE DIGITAL FLUOROGRAPHY DFX7000

Applicant Adac Laboratories

K number K834286

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JAA 1983-12-30

IMAGE INTENSIFIER TUBE W/HOUSING &

Applicant Varian Assoc., Inc.

K number K833641

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JAA 1983-12-08

CT SCANNING ACCESSORIES

Applicant Lds Hospital

K number K833531

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JAA 1983-12-08

DIGITAL RADIOGRAPHY SYS DUAL GANTRIES

Applicant American Science and Engineering, Inc.

K number K833237

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JAA 1983-11-21

DIGITAL FLUOROGRAPHIC X-RAY SYSTEM

Applicant General Electric Co.

K number K833530

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JAA 1983-11-21

REGISTREX 1000 DIGITAL RADIOGRAPHY SYS

Applicant Advanced Technology Laboratories, Inc.

K number K833230

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JAA 1982-11-04

HYPERLUX 30 IMAGE SYSTEM

Applicant Cgr Medical Corp.

K number K827489

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JAA 1982-03-04

PI808 MOBILE C-ARM IMAGE INTENSIFIER

Applicant Precise Optics

K number K820178

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JAA 1982-02-24

LATERAL ANGULATING FLUORO SUSPENSION

Applicant General Electric Co.

K number K820184

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JAA 1982-01-19

RDP-2000

Applicant Machlett Laboratories, Inc.

K number K813158

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JAA 1981-12-29

DIGITAL FLUROGRAPHIC IMAGING SYSTEM

Applicant Diasonics, Inc.

K number K813217

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JAA 1981-11-24

IBIS II

Applicant Cgr Medical Corp.

K number K812963

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JAA 1981-11-06

FLUORICON L300 IMAGE INTENSIFIER

Applicant General Electric Co.

K number K812775

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JAA 1981-10-13

LATERAL ANGULATING FLUORO SUSPENSION SYS

Applicant General Electric Co.

K number K812561

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JAA 1981-09-16

FLUORO AUTOMATIC BRIGHTNESS SYS

Applicant Keystone X-Ray, Inc.

K number K812217

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JAA 1981-07-28

CARDIAC 1000 TM

Applicant American Edwards Laboratories

K number K811094

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JAA 1981-06-23

DIGITAL NOISE REDUCER

Applicant Philips Medical Systems (Cleveland), Inc.

K number K811295

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JAA 1981-04-23

X-RAY IMAGE INTENSIFIER PRODUCTS

Applicant Instrumentation Camera, Inc.

K number K810716

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JAA 1981-03-11

DIGITAL RADIOGRAPHY SYSTEM

Applicant Adac Laboratories

K number K810364

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JAA 1981-03-02

SIRECON COMPACT

Applicant Siemens Corp.

K number K810189

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JAA 1981-01-09

DIGITAL FLUOROGRAPHIC X-RAY SYSTEM

Applicant General Electric Co.

K number K802953

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JAA 1980-10-23

DIGITAL RADIOGRAPHY SYSTEM

Applicant Adac Laboratories

K number K802150

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JAA 1980-09-26

DIGITAL SUBTRACTION RADIOGRAPHY SYSTEM

Applicant Technicare Corp.

K number K801948

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JAA 1980-07-21

SFX-90 TABLE/SPOTFILMER W/FLUORICON L200

Applicant General Electric Co.

K number K801320

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JAA 1980-06-26

PET-SCOPE II MODEL DIS-1611

Applicant Diagnostic Information, Inc.

K number K801166

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JAA 1980-05-14

ORBITOR

Applicant Philips Medical Systems (Cleveland), Inc.

K number K800639

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JAA 1979-12-20

P1806 MOBILE C-ARM IMAGE INTENSIFIER

Applicant Precise Optics

K number K792225

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JAA 1979-10-26

L/U ARM - NEURO - VASCULAR #B5080B

Applicant General Electric Co.

K number K791830

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JAA 1978-10-24

EVALUSKOP

Applicant Siemens Corp.

K number K781711

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JAA 1977-08-16

PET-TV X-RAY IMAGE INTENSIFIER SYSTEM

Applicant Diagnostic Information, Inc.

K number K771485

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JAA 1977-08-03

6 L.L. SYSTEM

Applicant Toshiba Medical Systems

K number K771298

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JAA 1977-07-01

TELHTHERAPY SIMULATOR AECL-CP, G-3200

Applicant Atomic Energy of Canada

K number K771096

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JAA 1977-03-01

FLUOROSCOPIC ASSEMBLY, IMAGE INTENS.

Applicant Litton Medical Systems

K number K770337

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JAA 1977-03-01

FLUOROSCOPE, C-ARM

Applicant Litton Medical Systems

K number K770333

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JAA 1976-12-29

PET-SCOPE

Applicant Diagnostic Information, Inc.

K number K761285

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