FDA 510(k) Applications for Medical Device Product Code "IZO"
(Generator, High-Voltage, X-Ray, Diagnostic)

FDA 510(k) Number Applicant Device Name Decision Date
K881387 ABSOLUTE X-RAY CORP. X-RAY GENERATING SYSTEM, TF 800 07/08/1988
K902637 ACOMA MEDICAL IMAGING, INC. FUTURUS 2001 X-RAY GENERATOR 08/03/1990
K791933 ADVANCED INSTRUMENT DEVELOPMENT, INC. CONVERSION CONTRACTOR TIMER KIT 11/13/1979
K872445 ADVANCED INSTRUMENT DEVELOPMENT, INC. POWER-AID INDEPENDENT X-RAY POWER SOURCE 08/12/1987
K925684 AFP IMAGING CORP. OLYMP-X,X-RAY GENERATOR 02/02/1993
K901951 AMERISYS MODEL# MPC 07/11/1990
K904397 BAY SHORE MEDICAL EQUIPMENT CORP. TEC 1410 11/13/1990
K922814 BAY SHORE MEDICAL EQUIPMENT CORP. TEC1410 ANATOMICAL PROGRAMMING GENERATOR-MODIFICAT 09/11/1992
K883154 BAY X-RAY, INC. SELDIX 325 TWO PULSE GENERATOR/CONTROL 09/06/1988
K894479 BENNETT X-RAY CORP. 30KW HIGH FREQ. RADIO. GENE. MODELS HFQ-30/HFQ30SE 09/12/1989
K945731 BENNETT X-RAY CORP. HFQ HIGH FREQUENCY RADIOGRAPHIC AND FLUROSCOPIC GENERATORS 02/15/1995
K905799 BENNETT X-RAY CORP. HFQ SERIES CONTROLS AND GENERATORS 02/26/1991
K935068 BENNETT X-RAY CORP. RADIOGRAPHIC GENERATOR HFQ-WHIS 12/13/1993
K910020 CAPINTEC INSTRUMENTS, INC. CAPINTEC THYROID UPTAKE SYSTEM-VARIOUS MODELS 04/08/1991
K864624 CAROLINA MEDICAL ELECTRONICS PROBE, UPTAKE, NUCLEAR 08/10/1987
K813051 CGR MEDICAL CORP. COMPTAR III 11/24/1981
K833846 CGR MEDICAL CORP. PROCESS 100 ST 12/16/1983
K904114 CONTINENTAL X-RAY CORP. ANATECH X-RAY GENERATOR 01/03/1991
K911562 CONTINENTAL X-RAY CORP. EDITOR MP 800/HF-850 X-RAY CONTROL AND GENERATOR 10/24/1991
K942100 CONTINENTAL X-RAY CORP. MODEL TM EP HIGH VOLTAGE GENERATOR 06/07/1994
K934686 CONTINENTAL X-RAY CORP. MOLYBDENUM/RHODIUM FILTERS 05/26/1994
K921875 CONTINENTAL X-RAY CORP. X-RAY CONTROL AND HI-VOLTAGE GENERATOR 10/15/1992
K913577 CONTROL-X, INC. MILESTONE MS 325 RADIOGRAPHIC X-RAY GENERATOR 11/05/1991
K913578 CONTROL-X, INC. MILESTONE MS 525 RADIOGRAPHIC X-RAY GENERATOR 11/01/1991
K952265 CONTROL-X, INC. MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATOR 07/06/1995
K920349 CONTROL-X, INC. PCX 1050HF RADIOGRAPHIC X-RAY GENERATOR 02/12/1993
K920351 CONTROL-X, INC. PCX 650HF RADIOGRAPHIC X-RAY 02/12/1993
K802941 CONTROTEC, INC. CINESCOPE III RADIOGRAPHIC GENERATOR 01/09/1981
K893681 CUSTOM MEDICAL PRODUCTS, LTD. MAMM-AIRE CP 07/20/1989
K950694 ELECTROMED INTL., LTD. COMPACT-X 03/31/1995
K852908 ELECTROMED INTL., LTD. EDEC 2000 11/29/1985
K871145 ELECTROMED INTL., LTD. EDEC 50C CONSTANT POTENTIAL X-RAY GENERATOR 03/31/1987
K875341 ELECTROMED INTL., LTD. EDEC 60 R/F 02/01/1988
K880050 ELECTROMED INTL., LTD. EDEC 60R 02/29/1988
K870851 ELECTROMED INTL., LTD. EDEC 80 CONSTANT POTENTIAL X-RAY GENERATOR 03/20/1987
K875342 ELECTROMED INTL., LTD. EDEC 90C 01/29/1988
K843443 ELECTROMED INTL., LTD. EDEC-100 03/01/1985
K902986 ELECTROMEK DIAGNOSTIC SYSTEMS, INC. G.E. DXD 325/350/350II/DXD 525/525II GENERATORS 02/13/1991
K902987 ELECTROMEK DIAGNOSTIC SYSTEMS, INC. G.E. DXS 350/550/650/650II SINGLE PHASE GENERATORS 12/26/1990
K902988 ELECTROMEK DIAGNOSTIC SYSTEMS, INC. G.E. MSI 850/850II/1250 THREE PHASE GENERATORS 12/19/1990
K902985 ELECTROMEK DIAGNOSTIC SYSTEMS, INC. G.E. MST 625/625II/MST 1050/1050II THREE PHASE GEN 12/19/1990
K884678 ELSCINT, INC. ESP 3-PHASE X-RAY GENERATORS 01/17/1989
K880525 FISCHER IMAGING CORP. 3 PHASE HIGH FREQ. DIAG. X-RAY GEN. MICRO-X 60HF 08/15/1988
K883976 FISCHER IMAGING CORP. CFX 625 12/13/1988
K950291 FISCHER IMAGING CORP. DIGITAL 625HF 03/23/1995
K860736 FISCHER IMAGING CORP. FISCHER IMAGING FX325R X-RAY GENERATOR 04/17/1986
K944148 FISCHER IMAGING CORP. MICRO X-30HF 09/16/1994
K944147 FISCHER IMAGING CORP. MICRO X-50 HF 09/16/1994
K944150 FISCHER IMAGING CORP. MICRO X-65 HF 09/16/1994
K944149 FISCHER IMAGING CORP. MICRO X-80 HF 09/16/1994
K884134 FISCHER IMAGING CORP. MICRO-X 100CP 10/21/1988
K912449 FISCHER IMAGING CORP. MICRO-X 15 HF 08/28/1991
K914266 FISCHER IMAGING CORP. MICRO-X 30 HF 11/27/1991
K914236 FISCHER IMAGING CORP. MICRO-X 50 HF 11/27/1991
K905695 FISCHER IMAGING CORP. MICRO-X 80HF 03/06/1991
K893674 FISCHER IMAGING CORP. RME 325R 07/20/1989
K930792 FISCHER IMAGING CORP. RSX 30HF 05/19/1993
K943504 FISCHER IMAGING CORP. RSX-525HF 08/17/1994
K880519 FISCHER IMAGING CORP. SINGLE PHASE DIAG. X-RAY GENERATOR MICRO-X 650 05/04/1988
K880532 FISCHER IMAGING CORP. SINGLE PHASE DIAGNOSTIC X-RAY GENERATOR FX 350 03/28/1988
K880521 FISCHER IMAGING CORP. SINGLE PHASE DIAGNOSTIC X-RAY GENERATOR FX-650 05/04/1988
K880524 FISCHER IMAGING CORP. THREE PHASE DIAGNOSTIC X-RAY GENERATOR MICRO-X 100 05/04/1988
K880523 FISCHER IMAGING CORP. THREE PHASE, DIAGNOSTIC GENERATOR MICRO-X 75 05/04/1988
K880522 FISCHER IMAGING CORP. THREE PHASE, DIAGNOSTIC X-RAY GENERATOR MICRO-X 80 05/04/1988
K931049 GE MEDICAL SYSTEMS ADVANTX SYSTEM 05/19/1993
K954666 GE MEDICAL SYSTEMS MPH50, MPH65, AND MPH80 11/24/1995
K892943 GE MEDICAL SYSTEMS MULTI PULSE POWER UNIT GENERATOR 05/22/1989
K943652 GE MEDICAL SYSTEMS VASCULAR MP X-RAY GENERATOR 08/22/1994
K922165 GENDEX CORP. ATC725, ATC525, AND AP300 07/27/1992
K854499 GENDEX CORP. GENDEX PRINCE 30 MEDICAL X-RAY GENERATOR 04/22/1986
K890083 GENDEX CORP. GX-2000 STATIONARY X-RAY GENERATOR 03/31/1989
K802548 GENERAL ELECTRIC CO. GENERATOR, HIGH VOLT, X-RAY, DIAG. MPX80 12/02/1980
K802549 GENERAL ELECTRIC CO. GENERATOR, HIGH VOLT, X-RAY, MPX 100 12/02/1980
K802550 GENERAL ELECTRIC CO. GENERATOR, HIGH VOLT, X-RAY, MPX 125 12/02/1980
K802551 GENERAL ELECTRIC CO. GENERATOR, HIGH VOLT, X-RAY, MPX100/125 12/02/1980
K921951 GENERAL ELECTRIC CO. MPG 65-80-100 X-RAY GENERATOR AND CONTROL 07/21/1992
K770007 GENERAL ELECTRIC CO. MPX 100 01/18/1977
K770008 GENERAL ELECTRIC CO. MPX 125 01/18/1977
K770006 GENERAL ELECTRIC CO. MPX 80 01/18/1977
K862682 GENERAL ELECTRIC CO. MVP GENERATOR, CATALOG NO. H8018 07/29/1986
K940227 GENERAL ELECTRIC CO. SCPU X-RAY GENERATOR 04/28/1994
K862800 GENERAL ELECTRIC CO. SMX GENERATOR 08/14/1986
K842348 GENERAL ELECTRIC CO. SPX GENERATOR 08/17/1984
K881386 GENERAL MEDICAL MERATE S.P.A. X-RAY GENERATING SYSTEM TF 1000 07/08/1988
K851011 HOFMANN X-RAY OF AMERICA, INC. HOFMANN G-S60 SINGLE PHASE X-RAY GENERATOR 04/10/1985
K910650 HOFMANN-NAGEL MEDICAL SYSTEMS, INC. SELECTOR MD (50KW AND 80 KW) 06/06/1991
K926365 IMAGING AND X-RAY INTL., INC. MAGMA XHF-30, XHF-40, XHF-50 03/26/1993
K933777 INNERSCAN, INC. CONCEPT ONE 12/13/1993
K760568 LITTON MEDICAL SYSTEMS SINGLE PHASE X-RAY CONTROLS & HV GENERATORS 09/15/1976
K760569 LITTON MEDICAL SYSTEMS THREE PHASE X-RAY CONTROLS & HV GENERATORS 09/15/1976
K770338 LITTON MEDICAL SYSTEMS X-RAY CONTROL & X-RAY HV GENERATOR 03/01/1977
K953831 NUCLETRON-OLDELFT CORP. N 800 HF 09/08/1995
K950037 OLDELFT CORP. OF AMERICA N 800 HF 02/15/1995
K913222 OLYMPIC CONTROLS CORP. OPTIMA 12/20/1991
K933650 PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. PHILIPS XRG 90 X-RAY GENERATOR SYSTEM 10/07/1993
K801408 PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. CINESCOPE III 07/28/1980
K811198 PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. ECCO GENERATOR 06/29/1981
K931998 PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. LCR GENERATOR 07/27/1993
K850823 PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. SRX 200 DIAGNOSTIC X-RAY, HIGH VOLTAGE GENERATOR 04/10/1985
K802996 PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. VECTOR-100 X-RAY GENERATOR 01/09/1981
K925105 PHILIPS MEDICAL SYSTEMS, INC. PHILIPS MEDIO CP FAMILY 12/28/1992
K925844 PHILIPS MEDICAL SYSTEMS, INC. PHILIPS SUPER CP FAMILY 12/28/1992
K864339 PORTA RAY, INC. PORTA RAY MODEL 325 12/15/1986
K921516 PRECISE OPTICS PHOTO MEDIC EQUIPMENT, INC. P2900 X-RAY GENERATOR 05/28/1992
K895969 RADKOR, INC. RADKOR DXG-650R 11/13/1989
K881696 RADKOR, INC. RADKOR XG-325 09/02/1988
K883081 RADKOR, INC. RADKOR, XG-515 09/02/1988
K883431 RAYMAX MEDICAL CORP. RAYMAX 2100 MODELS 2130 & 2136 09/12/1988
K950041 SCOTT IMAGING INTL., INC. SII 360 APR 03/21/1995
K950040 SCOTT IMAGING INTL., INC. SII 525 APR 03/21/1995
K934967 SHIMADZU CORP. SHIMADZU UD150L-R X-RAY HIGH VOLTAGE GENERATOR 12/13/1993
K952822 SHIMADZU CORP. SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G 07/12/1995
K933471 SHIMADZU CORP. SHIMADZU X-RAY HIGH VOLTAGE GENERATOR AUD150G 11/24/1993
K942731 SHIMADZU CORP. SHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GR 10/13/1994
K913062 SHIMADZU MEDICAL SYSTEMS SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B-10 09/16/1991
K913065 SHIMADZU MEDICAL SYSTEMS SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150L 09/16/1991
K913064 SHIMADZU MEDICAL SYSTEMS SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD 150L 09/16/1991
K913063 SHIMADZU MEDICAL SYSTEMS SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD150B-10 09/16/1991
K903942 SHIMADZU MEDICAL SYSTEMS SHIMADZU X-RAY HIGH VOLTAGE GENERATPR AHD150G 10/03/1990
K911280 SHIMADZU MEDICAL SYSTEMS SHIMADZU X-RAY HIGH-VOLTAGE GENERATOR XUD150B 06/17/1991
K911339 SHIMADZU MEDICAL SYSTEMS SHIMADZU X-RAY HIGH-VOLTAGE GENERATOR XUD150K 04/16/1991
K945452 SHIMADZU MEDICAL SYSTEMS UD 150L-F 03/21/1995
K945453 SHIMADZU MEDICAL SYSTEMS UD 150L-R II 03/21/1995
K920730 SHIMADZU MEDICAL SYSTEMS X-RAY HIGH VOLTAGE GENERATOR ED 125L 04/27/1992
K874946 SHIMADZU PRECISION INSTRUMENTS, INC. SHIMADZU X-RAY HIGH VOLTAGE GENERATOR HD150G-60 03/03/1988
K881795 SHIMADZU PRECISION INSTRUMENTS, INC. SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150K 07/01/1988
K792393 SIEMENS CORP. GIGANTOS 1012 MP 12/20/1979
K780742 SIEMENS CORP. INTRAORAL DENTAL X-RAY GENERATOR 07/27/1978
K792392 SIEMENS CORP. POLYPHOS 12/20/1979
K812616 SIEMENS CORP. POLYPHOS 500 10/13/1981
K820112 SIEMENS CORP. SIEMENS POLYDOROS 800 02/24/1982
K791214 SIEMENS CORP. TRIDOROS 712 07/30/1979
K924078 SIEMENS MEDICAL SOLUTIONS USA, INC. POLYDOROS C 01/26/1993
K933240 SIEMENS MEDICAL SOLUTIONS USA, INC. POLYDOROS IS 09/07/1993
K950883 SIEMENS MEDICAL SOLUTIONS USA, INC. POLYDOROS SX 65 AND 80 04/03/1995
K923786 SIEMENS MEDICAL SOLUTIONS USA, INC. POLYDOROS XS50 AND SX80 12/17/1992
K931930 SIEMENS MEDICAL SOLUTIONS USA, INC. POYDOROS LX 09/07/1993
K850117 SUMMIT INDUSTRIES, INC. XMA 325 (X-RAY GENERATOR) 04/09/1985
K915227 SWISS RAY MEDICAL SYSTEMS GEN-X 800/500 01/09/1992
K915339 SWISSRAY FINATECH, INC. GEN-X 800/300 01/09/1992
K914302 SWISSRAY FINATECH, INC. GEN-X 800/650 10/30/1991
K914301 SWISSRAY FINATECH, INC. GEN-X 800/800 10/30/1991
K820307 TECNOMED, INC. TECNOMED GENERATOR, RADIOGRAPH., 3 PHASE 03/05/1982
K873544 THOMSON-CGR MEDICAL CORP. MPG-50 X-RAY GENERATOR 10/26/1987
K860203 TINGLE X-RAY PRODUCTS, INC. TXR 325 X-RAY CONTROL WITH HIGH VOLTAGE GENERATOR 01/30/1986
K904043 TOSHIBA AMERICA MEDICAL SYSTEMS, INC. KXO-80C/80D 11/29/1990
K945668 TOSHIBA AMERICA MEDICAL SYSTEMS, INC. KXO-80G 12/27/1994
K771295 TOSHIBA MEDICAL SYSTEMS X-RAY GENERATOR MODEL KX0-825 08/03/1977
K771294 TOSHIBA MEDICAL SYSTEMS X-RAY GENERATOR MODEL KXO-15 08/03/1977
K892657 TRANSWORLD X-RAY CORP. SENSIMAT 06/23/1989
K890066 TRANSWORLD X-RAY CORP. STAR 36 03/28/1989
K872357 TRANSWORLD X-RAY CORP. TRANSWORLD 360V, MODEL A1-4040 07/15/1987
K881886 U.S. IMAGING, INC. MODIFIED X-RAY CONTROLS, MODEL ED125L AND ED150L 08/04/1988
K900062 U.S. IMAGING, INC. U.S.I. MODEL 1012, REMOTE FLUOROSCOPIC CONTROL 02/05/1990
K801808 VALMET INDUS. MACH. & PROD., INC. BR 2002 X-RAY GENERATOR SYSTEM 09/26/1980
K942778 VARIAN ASSOC., INC. MODEL VPW2877F8, "MAMMO 5" POWER SUPPLY 07/29/1994
K902106 VARIAN ASSOC., INC. VPW 2877D5, X-RAY POWER SUPPLY 08/10/1990
K953582 VARIAN CANADA, INC. HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR 09/26/1995
K910820 VARIAN CANADA, INC. VPW 2877E6 X-RAY POWER SUPPLY 03/07/1991
K904169 VARIAN CANADA, INC. VPW 2903 A-1 -208V, B2-440V,C3-240V X-RAY SUPPLY 02/19/1991
K905855 VARIAN CANADA, INC. VPW2877E7 X RAY POWER SUPPLY 02/13/1991
K913234 VARIAN CANADA, INC. VPW2906A1: 480V, 3 PHASE, X-RAY POWER SUPPLY 09/23/1991
K820593 XONICS MEDICAL SYSTEMS, INC. ESP SERIES (X-RAY GENERATORS 03/19/1982


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