Generator, High-Voltage, X-Ray, Diagnostic
FDA product code IZO · Class I (low risk) · 21 CFR 892.1700 · Radiology
163510(k) clearances
0PMA approvals
4recalls
Manufacturers
- Fischer Imaging Corp. 22
- General Electric Co. 12
- Shimadzu Medical Systems 10
- Electromed Intl., Ltd. 8
- Siemens Corp. 6
- Varian Canada, Inc. 5
- Siemens Medical Solutions USA, Inc. 5
- Continental X-Ray Corp. 5
- Philips Medical Systems (Cleveland) Inc 5
- Control-X, Inc. 5
- Electromek Diagnostic Systems, Inc. 4
- Shimadzu Corp. 4
- Bennett X-Ray Corp. 4
- GE Medical Systems, LLC 4
- Swissray Finatech, Inc. 3
- Radkor, Inc. 3
- Gendex Corp. 3
- Transworld X-Ray Corp. 3
- Litton Medical Systems 3
- Bay Shore Medical Equipment Corp. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K954666 | MPH50, MPH65, and MPH80IZO · Traditional | GE Medical Systems | 11/24/1995SE |
| K953582 | HFX350, 30KW, 300MA, 1 or 3 Phase Radiographic & Fluoroscopic X-Ray GeneratorIZO · Traditional | Varian Canada, Inc. | 09/26/1995SE |
| K953831 | N 800 HFIZO · Traditional | Nucletron-Oldelft Corp. | 09/08/1995SE |
| K952822 | Shimadzu X-Ray High Viltage Generator AHD150GIZO · Traditional | Shimadzu Corp. | 07/12/1995SE |
| K952265 | Milestonw 350/450/550HF, PCX N350/450/550HF, Top-X 350/450/550HF Radiographic X-Ray…IZO · Traditional | Control-X, Inc. | 07/06/1995SE |
| K950883 | Polydoros SX 65 and 80IZO · Traditional | Siemens Medical Solutions USA, Inc. | 04/03/1995SE |
| K950694 | Compact-XIZO · Traditional | Electromed Intl., Ltd. | 03/31/1995SE |
| K950291 | Digital 625HFIZO · Traditional | Fischer Imaging Corp. | 03/23/1995SE |
| K950041 | Sii 360 AprIZO · Traditional | Scott Imaging Intl., Inc. | 03/21/1995SE |
| K950040 | Sii 525 AprIZO · Traditional | Scott Imaging Intl., Inc. | 03/21/1995SE |
| K945453 | Ud 150L-R IIIZO · Traditional | Shimadzu Medical Systems | 03/21/1995SE |
| K945452 | Ud 150L-FIZO · Traditional | Shimadzu Medical Systems | 03/21/1995SE |
| K950037 | N 800 HFIZO · Traditional | Oldelft Corp. of America | 02/15/1995SE |
| K945731 | HFQ High Frequency Radiographic and Fluroscopic GeneratorsIZO · Traditional | Bennett X-Ray Corp. | 02/15/1995SE |
| K945668 | KXO-80GIZO · Traditional | Toshiba America Medical Systems, In.C | 12/27/1994SE |
| K942731 | Shimazu Whole Body X-Ray CT Scanner SCT-4800TF/GRIZO · Traditional | Shimadzu Corp. | 10/13/1994SE |
| K944150 | Micro X-65 HFIZO · Traditional | Fischer Imaging Corp. | 09/16/1994SE |
| K944149 | Micro X-80 HFIZO · Traditional | Fischer Imaging Corp. | 09/16/1994SE |
| K944148 | Micro X-30HFIZO · Traditional | Fischer Imaging Corp. | 09/16/1994SE |
| K944147 | Micro X-50 HFIZO · Traditional | Fischer Imaging Corp. | 09/16/1994SE |
| K943652 | Vascular MP X-Ray GeneratorIZO · Traditional | GE Medical Systems | 08/22/1994SE |
| K943504 | RSX-525HFIZO · Traditional | Fischer Imaging Corp. | 08/17/1994SE |
| K942778 | Model VPW2877F8, Mammo 5 Power SupplyIZO · Traditional | Varian Assoc., Inc. | 07/29/1994SE |
| K942100 | Model TM Ep High Voltage GeneratorIZO · Traditional | Continental X-Ray Corp. | 06/07/1994SE |
| K934686 | Molybdenum/Rhodium FiltersIZO · Traditional | Continental X-Ray Corp. | 05/26/1994SE |
| K940227 | Scpu X-Ray GeneratorIZO · Traditional | General Electric Co. | 04/28/1994SE |
| K935068 | Radiographic Generator Hfq-WhisIZO · Traditional | Bennett X-Ray Corp. | 12/13/1993SE |
| K934967 | Shimadzu UD150L-R X-Ray High Voltage GeneratorIZO · Traditional | Shimadzu Corp. | 12/13/1993SE |
| K933777 | Concept OneIZO · Traditional | Innerscan, Inc. | 12/13/1993SE |
| K933471 | Shimadzu X-Ray High Voltage Generator AUD150GIZO · Traditional | Shimadzu Corp. | 11/24/1993SE |
| K933650 | Philips XRG 90 X-Ray Generator SystemIZO · Traditional | Philips Medical Systems North America, Inc. | 10/07/1993SE |
| K933240 | Polydoros IsIZO · Traditional | Siemens Medical Solutions USA, Inc. | 09/07/1993SE |
| K931930 | Poydoros LXIZO · Traditional | Siemens Medical Solutions USA, Inc. | 09/07/1993SE |
| K931998 | LCR GeneratorIZO · Traditional | Philips Medical Systems (Cleveland), Inc. | 07/27/1993SE |
| K931049 | Advantx SystemIZO · Traditional | GE Medical Systems | 05/19/1993SE |
| K930792 | RSX 30HFIZO · Traditional | Fischer Imaging Corp. | 05/19/1993SE |
| K926365 | Magma XHF-30, XHF-40, XHF-50IZO · Traditional | Imaging and X-Ray Intl., Inc. | 03/26/1993SE |
| K920351 | PCX 650HF Radiographic X-RayIZO · Traditional | Control-X, Inc. | 02/12/1993SE |
| K920349 | PCX 1050HF Radiographic X-Ray GeneratorIZO · Traditional | Control-X, Inc. | 02/12/1993SE |
| K925684 | Olymp-X,X-Ray GeneratorIZO · Traditional | Afp Imaging Corp. | 02/02/1993SE |
| K924078 | Polydoros CIZO · Traditional | Siemens Medical Solutions USA, Inc. | 01/26/1993SE |
| K925844 | Philips Super CP FamilyIZO · Traditional | Philips Medical Systems, Inc. | 12/28/1992SE |
| K925105 | Philips Medio CP FamilyIZO · Traditional | Philips Medical Systems, Inc. | 12/28/1992SE |
| K923786 | Polydoros XS50 and SX80IZO · Traditional | Siemens Medical Solutions USA, Inc. | 12/17/1992SE |
| K921875 | X-Ray Control and Hi-Voltage GeneratorIZO · Traditional | Continental X-Ray Corp. | 10/15/1992SE |
| K922814 | TEC1410 Anatomical Programming Generator-ModificatIZO · Traditional | Bay Shore Medical Equipment Corp. | 09/11/1992SE |
| K922165 | ATC725, ATC525, and AP300IZO · Traditional | Gendex Corp. | 07/27/1992SE |
| K921951 | MPG 65-80-100 X-Ray Generator and ControlIZO · Traditional | General Electric Co. | 07/21/1992SE |
| K921516 | P2900 X-Ray GeneratorIZO · Traditional | Precise Optics Photo Medic Equipment, Inc. | 05/28/1992SE |
| K920730 | X-Ray High Voltage Generator Ed 125LIZO · Traditional | Shimadzu Medical Systems | 04/27/1992SE |
| K915339 | Gen-X 800/300IZO · Traditional | Swissray Finatech, Inc. | 01/09/1992SE |
| K915227 | Gen-X 800/500IZO · Traditional | Swiss Ray Medical Systems | 01/09/1992SE |
| K913222 | OptimaIZO · Traditional | Olympic Controls Corp. | 12/20/1991SE |
| K914266 | Micro-X 30 HFIZO · Traditional | Fischer Imaging Corp. | 11/27/1991SE |
| K914236 | Micro-X 50 HFIZO · Traditional | Fischer Imaging Corp. | 11/27/1991SE |
| K913577 | Milestone MS 325 Radiographic X-Ray GeneratorIZO · Traditional | Control-X, Inc. | 11/05/1991SE |
| K913578 | Milestone MS 525 Radiographic X-Ray GeneratorIZO · Traditional | Control-X, Inc. | 11/01/1991SE |
| K914302 | Gen-X 800/650IZO · Traditional | Swissray Finatech, Inc. | 10/30/1991SE |
| K914301 | Gen-X 800/800IZO · Traditional | Swissray Finatech, Inc. | 10/30/1991SE |
| K911562 | Editor MP 800/HF-850 X-Ray Control and GeneratorIZO · Traditional | Continental X-Ray Corp. | 10/24/1991SE |
| K913234 | VPW2906A1: 480V, 3 Phase, X-Ray Power SupplyIZO · Traditional | Varian Canada, Inc. | 09/23/1991SE |
| K913065 | Shimadzu X-Ray High Voltage Generator UD150LIZO · Traditional | Shimadzu Medical Systems | 09/16/1991SE |
| K913064 | Shimadzu X-Ray High Voltage Generator Xud 150LIZO · Traditional | Shimadzu Medical Systems | 09/16/1991SE |
| K913063 | Shimadzu X-Ray High Voltage Generator XUD150B-10IZO · Traditional | Shimadzu Medical Systems | 09/16/1991SE |
| K913062 | Shimadzu X-Ray High Voltage Generator UD150B-10IZO · Traditional | Shimadzu Medical Systems | 09/16/1991SE |
| K912449 | Micro-X 15 HFIZO · Traditional | Fischer Imaging Corp. | 08/28/1991SE |
| K911280 | Shimadzu X-Ray High-Voltage Generator XUD150BIZO · Traditional | Shimadzu Medical Systems | 06/17/1991SE |
| K910650 | Selector MD (50KW and 80 KW)IZO · Traditional | Hofmann-Nagel Medical Systems, Inc. | 06/06/1991SE |
| K911339 | Shimadzu X-Ray High-Voltage Generator XUD150KIZO · Traditional | Shimadzu Medical Systems | 04/16/1991SE |
| K910020 | Capintec Thyroid Uptake System-Various ModelsIZO · Traditional | Capintec Instruments, Inc. | 04/08/1991SE |
| K910820 | VPW 2877E6 X-Ray Power SupplyIZO · Traditional | Varian Canada, Inc. | 03/07/1991SE |
| K905695 | Micro-X 80HFIZO · Traditional | Fischer Imaging Corp. | 03/06/1991SE |
| K905799 | HFQ Series Controls and GeneratorsIZO · Traditional | Bennett X-Ray Corp. | 02/26/1991SE |
| K904169 | VPW 2903 A-1 -208V, B2-440V,C3-240V X-Ray SupplyIZO · Traditional | Varian Canada, Inc. | 02/19/1991SE |
| K905855 | VPW2877E7 X Ray Power SupplyIZO · Traditional | Varian Canada, Inc. | 02/13/1991SE |
| K902986 | G.E. DXD 325/350/350II/DXD 525/525II GeneratorsIZO · Traditional | Electromek Diagnostic Systems, Inc. | 02/13/1991SE |
| K904114 | Anatech X-Ray GeneratorIZO · Traditional | Continental X-Ray Corp. | 01/03/1991SE |
| K902987 | G.E. DXS 350/550/650/650II Single Phase GeneratorsIZO · Traditional | Electromek Diagnostic Systems, Inc. | 12/26/1990SE |
| K902988 | G.E. Msi 850/850II/1250 Three Phase GeneratorsIZO · Traditional | Electromek Diagnostic Systems, Inc. | 12/19/1990SE |
| K902985 | G.E. MST 625/625II/MST 1050/1050II Three Phase GenIZO · Traditional | Electromek Diagnostic Systems, Inc. | 12/19/1990SE |
| K904043 | KXO-80C/80DIZO · Traditional | Toshiba America Medical Systems, In.C | 11/29/1990SE |
| K904397 | Tec 1410IZO · Traditional | Bay Shore Medical Equipment Corp. | 11/13/1990SE |
| K903942 | Shimadzu X-Ray High Voltage Generatpr AHD150GIZO · Traditional | Shimadzu Medical Systems | 10/03/1990SE |
| K902106 | VPW 2877D5, X-Ray Power SupplyIZO · Traditional | Varian Assoc., Inc. | 08/10/1990SE |
| K902637 | Futurus 2001 X-Ray GeneratorIZO · Traditional | Acoma Medical Imaging, Inc. | 08/03/1990SE |
| K901951 | Model# MPCIZO · Traditional | Amerisys | 07/11/1990SE |
| K900062 | U.S.I. Model 1012, Remote Fluoroscopic ControlIZO · Traditional | U.S. Imaging, Inc. | 02/05/1990SE |
| K895969 | Radkor DXG-650RIZO · Traditional | Radkor, Inc. | 11/13/1989SE |
| K894479 | 30KW High Freq. Radio. Gene. Models HFQ-30/HFQ30SEIZO · Traditional | Bennett X-Ray Corp. | 09/12/1989SE |
| K893681 | Mamm-Aire CPIZO · Traditional | Custom Medical Products, Ltd. | 07/20/1989SE |
| K893674 | Rme 325RIZO · Traditional | Fischer Imaging Corp. | 07/20/1989SE |
| K892657 | SensimatIZO · Traditional | Transworld X-Ray Corp. | 06/23/1989SE |
| K892943 | Multi Pulse Power Unit GeneratorIZO · Traditional | GE Medical Systems | 05/22/1989SE |
| K890083 | GX-2000 Stationary X-Ray GeneratorIZO · Traditional | Gendex Corp. | 03/31/1989SE |
| K890066 | Star 36IZO · Traditional | Transworld X-Ray Corp. | 03/28/1989SE |
| K884678 | Esp 3-PHASE X-Ray GeneratorsIZO · Traditional | Elscint, Inc. | 01/17/1989SE |
| K883976 | CFX 625IZO · Traditional | Fischer Imaging Corp. | 12/13/1988SE |
| K884134 | Micro-X 100CPIZO · Traditional | Fischer Imaging Corp. | 10/21/1988SE |
| K883431 | Raymax 2100 Models 2130 & 2136IZO · Traditional | Raymax Medical Corp. | 09/12/1988SE |
| K883154 | Seldix 325 Two Pulse Generator/ControlIZO · Traditional | Bay X-Ray, Inc. | 09/06/1988SE |
| K883081 | Radkor, XG-515IZO · Traditional | Radkor, Inc. | 09/02/1988SE |
| K881696 | Radkor XG-325IZO · Traditional | Radkor, Inc. | 09/02/1988SE |
| K880525 | 3 Phase High Freq. Diag. X-Ray Gen. Micro-X 60HFIZO · Traditional | Fischer Imaging Corp. | 08/15/1988SE |
| K881886 | Modified X-Ray Controls, Model ED125L and ED150LIZO · Traditional | U.S. Imaging, Inc. | 08/04/1988SE |
| K881387 | X-Ray Generating System, TF 800IZO · Traditional | Absolute X-Ray Corp. | 07/08/1988SE |
| K881386 | X-Ray Generating System TF 1000IZO · Traditional | General Medical Merate S.P.A | 07/08/1988SE |
| K881795 | Shimadzu X-Ray High Voltage Generator UD150KIZO · Traditional | Shimadzu Precision Instruments, Inc. | 07/01/1988SE |
| K880524 | Three Phase Diagnostic X-Ray Generator Micro-X 100IZO · Traditional | Fischer Imaging Corp. | 05/04/1988SE |
| K880523 | Three Phase, Diagnostic Generator Micro-X 75IZO · Traditional | Fischer Imaging Corp. | 05/04/1988SE |
| K880522 | Three Phase, Diagnostic X-Ray Generator Micro-X 80IZO · Traditional | Fischer Imaging Corp. | 05/04/1988SE |
| K880521 | Single Phase Diagnostic X-Ray Generator FX-650IZO · Traditional | Fischer Imaging Corp. | 05/04/1988SE |
| K880519 | Single Phase Diag. X-Ray Generator Micro-X 650IZO · Traditional | Fischer Imaging Corp. | 05/04/1988SE |
| K880532 | Single Phase Diagnostic X-Ray Generator FX 350IZO · Traditional | Fischer Imaging Corp. | 03/28/1988SE |
| K874946 | Shimadzu X-Ray High Voltage Generator HD150G-60IZO · Traditional | Shimadzu Precision Instruments, Inc. | 03/03/1988SE |
| K880050 | Edec 60RIZO · Traditional | Electromed Intl., Ltd. | 02/29/1988SE |
| K875341 | Edec 60 R/FIZO · Traditional | Electromed Intl., Ltd. | 02/01/1988SE |
| K875342 | Edec 90CIZO · Traditional | Electromed Intl., Ltd. | 01/29/1988SE |
| K873544 | MPG-50 X-Ray GeneratorIZO · Traditional | Thomson-Cgr Medical Corp. | 10/26/1987SE |
| K872445 | Power-Aid Independent X-Ray Power SourceIZO · Traditional | Advanced Instrument Development, Inc. | 08/12/1987SE |
| K864624 | Probe, Uptake, NuclearIZO · Traditional | Carolina Medical Electronics | 08/10/1987SE |
| K872357 | Transworld 360V, Model A1-4040IZO · Traditional | Transworld X-Ray Corp. | 07/15/1987SE |
| K871145 | Edec 50C Constant Potential X-Ray GeneratorIZO · Traditional | Electromed Intl., Ltd. | 03/31/1987SE |
| K870851 | Edec 80 Constant Potential X-Ray GeneratorIZO · Traditional | Electromed Intl., Ltd. | 03/20/1987SE |
| K864339 | Porta Ray Model 325IZO · Traditional | Porta Ray, Inc. | 12/15/1986SE |
| K862800 | SMX GeneratorIZO · Traditional | General Electric Co. | 08/14/1986SE |
| K862682 | MVP Generator, Catalog No. H8018IZO · Traditional | General Electric Co. | 07/29/1986SE |
| K854499 | Gendex Prince 30 Medical X-Ray GeneratorIZO · Traditional | Gendex Corp. | 04/22/1986SE |
| K860736 | Fischer Imaging FX325R X-Ray GeneratorIZO · Traditional | Fischer Imaging Corp. | 04/17/1986SE |
| K860203 | TXR 325 X-Ray Control with High Voltage GeneratorIZO · Traditional | Tingle X-Ray Products, Inc. | 01/30/1986SE |
| K852908 | Edec 2000IZO · Traditional | Electromed Intl., Ltd. | 11/29/1985SE |
| K851011 | Hofmann G-S60 Single Phase X-Ray GeneratorIZO · Traditional | Hofmann X-Ray of America, Inc. | 04/10/1985SE |
| K850823 | SRX 200 Diagnostic X-Ray, High Voltage GeneratorIZO · Traditional | Philips Medical Systems (Cleveland), Inc. | 04/10/1985SE |
| K850117 | Xma 325 (X-Ray Generator)IZO · Traditional | Summit Industries, Inc. | 04/09/1985SE |
| K843443 | EDEC-100IZO · Traditional | Electromed Intl., Ltd. | 03/01/1985SE |
| K842348 | SPX GeneratorIZO · Traditional | General Electric Co. | 08/17/1984SE |
| K833846 | Process 100 STIZO · Traditional | Cgr Medical Corp. | 12/16/1983SE |
| K820593 | Esp Series (X-Ray GeneratorsIZO · Traditional | Xonics Medical Systems, Inc. | 03/19/1982SE |
| K820307 | Tecnomed Generator, Radiograph., 3 PhaseIZO · Traditional | Tecnomed, Inc. | 03/05/1982SE |
| K820112 | Siemens Polydoros 800IZO · Traditional | Siemens Corp. | 02/24/1982SE |
| K813051 | Comptar IIIIZO · Traditional | Cgr Medical Corp. | 11/24/1981SE |
| K812616 | Polyphos 500IZO · Traditional | Siemens Corp. | 10/13/1981SE |
| K811198 | Ecco GeneratorIZO · Traditional | Philips Medical Systems (Cleveland), Inc. | 06/29/1981SE |
| K802996 | VECTOR-100 X-Ray GeneratorIZO · Traditional | Philips Medical Systems (Cleveland), Inc. | 01/09/1981SE |
| K802941 | Cinescope III Radiographic GeneratorIZO · Traditional | Controtec, Inc. | 01/09/1981SE |
| K802551 | Generator, High Volt, X-Ray, MPX100/125IZO · Traditional | General Electric Co. | 12/02/1980SE |
| K802550 | Generator, High Volt, X-Ray, MPX 125IZO · Traditional | General Electric Co. | 12/02/1980SE |
| K802549 | Generator, High Volt, X-Ray, MPX 100IZO · Traditional | General Electric Co. | 12/02/1980SE |
| K802548 | Generator, High Volt, X-Ray, Diag. MPX80IZO · Traditional | General Electric Co. | 12/02/1980SE |
| K801808 | BR 2002 X-Ray Generator SystemIZO · Traditional | Valmet Indus. Mach. & Prod., Inc. | 09/26/1980SE |
| K801408 | Cinescope IIIIZO · Traditional | Philips Medical Systems (Cleveland), Inc. | 07/28/1980SE |
| K792393 | Gigantos 1012 MPIZO · Traditional | Siemens Corp. | 12/20/1979SE |
| K792392 | PolyphosIZO · Traditional | Siemens Corp. | 12/20/1979SE |
| K791933 | Conversion Contractor Timer KitIZO · Traditional | Advanced Instrument Development, Inc. | 11/13/1979SE |
| K791214 | Tridoros 712IZO · Traditional | Siemens Corp. | 07/30/1979SE |
| K780742 | Intraoral Dental X-Ray GeneratorIZO · Traditional | Siemens Corp. | 07/27/1978SE |
| K771295 | X-Ray Generator Model KX0-825IZO · Traditional | Toshiba Medical Systems | 08/03/1977SE |
| K771294 | X-Ray Generator Model KXO-15IZO · Traditional | Toshiba Medical Systems | 08/03/1977SE |
| K770338 | X-Ray Control & X-Ray HV GeneratorIZO · Traditional | Litton Medical Systems | 03/01/1977SE |
| K770008 | MPX 125IZO · Traditional | General Electric Co. | 01/18/1977SE |
| K770007 | MPX 100IZO · Traditional | General Electric Co. | 01/18/1977SE |
| K770006 | MPX 80IZO · Traditional | General Electric Co. | 01/18/1977SE |
| K760569 | Three Phase X-Ray Controls & HV GeneratorsIZO · Traditional | Litton Medical Systems | 09/15/1976SE |
| K760568 | Single Phase X-Ray Controls & HV GeneratorsIZO · Traditional | Litton Medical Systems | 09/15/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0918-2017 Class II | Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION safire II/17…Shimadzu Medical Systems is recalling the Shimadzu X-ray High Voltage Generator due to the possibility of… | Shimadzu Medical Systems | 11/20/2016Terminated |
| Z-0905-2011 | BuckyDiagnost general purpose x-ray system with Optimus Generator. General Purpose…Affected systems were determined not to prevent run-on of a selected technique factor if the technique… | Philips Healthcare Inc. | 01/17/2011Terminated |
| Z-1904-2010 | Hydradjust IV DR Urological Table Sedecal Generator (p/n 750732 - 64W generator & p/n…Covidien received complaints of the Sedecal Generator failing and producing smoke at customer sites. The… | Mallinckrodt Inc | 06/14/2010Terminated |
| Z-0200-2009 | Monitor suspensions used with Advantx Legacy, RFX Classical, SFX-90, Model #…GE Healthcare has recently become aware of a potential risk of monitor dropping associated with the monitor… | GE Healthcare | 03/09/2007Terminated |