FDA.reportPublic FDA data

Mobile general-purpose fluoroscopic x-ray system, digital

Definition
A mobile (within an imaging facility) general-purpose diagnostic fluoroscopic x-ray system that uses a C-arm and digital techniques for image capture, display and manipulation and is designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging capabilities. It includes spot-film capabilities in addition to the fluoroscopic features and is intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time. It is frequently used in conjunction with an ingested or injected x-ray contrast medium. Images can be both real-time and delayed formats.
GUDID devices
107
Last updated
2026-09-04 23:13:00

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
03701311500407SURGIVISIOECENTIAL ROBOTICSI000012023-03-01
03701311501121SURGIVISIO DEVICEECENTIAL ROBOTICSI010012023-09-04
00195278685001OECGE Hualun Medical Systems Co., LtdOne ASD2025-01-09
04547410582901FDR CROSS SlimFUJIFILM CORPORATIONDR-XD 3000 SLIM MBL E2026-08-14
00195278502582OECGE Hualun Medical Systems Co., LtdElite MiniView2022-03-04
00860014944611nView s1 with nav optionNVIEW MEDICAL INC.s1 with nav option2026-07-08
00860008443700TRONXORAN TECHNOLOGIES LLC110502023-01-12
08055186671225A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLARCO FP-Rk0521S2026-05-21
08055186671232A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLARCO FP-Rk2021S2026-05-21
08055186671249A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLARCO FP-Rk0530S2026-05-21
08055186671256A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLARCO FP-Rk2030S2026-05-21
08800019200093NAECOTRONAnyview-500R2016-11-05
08800019200253NAECOTRONAnyview-240DR2018-03-29
08800019200260NAECOTRONAnyview-320DR2018-03-29
08800019200277NAECOTRONAnyview-500DR2018-03-29
08809246620001SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIEDGEMSS MEDICAL SYSTEMS CO.,LTD.KMC-9502016-09-24
08809246620018 IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILEGEMSS MEDICAL SYSTEMS CO.,LTD.SPINEL 3G2016-09-24
08809246620025Image-intensified fluoroscopic x-ray system, mobileGEMSS MEDICAL SYSTEMS CO.,LTD.KMC-6502016-09-24
08809246620049Interventional Fluoroscopic Mobile X-ray SystemGEMSS MEDICAL SYSTEMS CO.,LTD.SPINEL 12HD2018-02-05
08800098700156XPLUS 35 SeriesGEMSS Healthcare Co., Ltd.XPLUS 35FD2026-01-16
08800098700163XPLUS 35 SeriesGEMSS Healthcare Co., Ltd.XPLUS 352026-01-16
08809244060618GenorayGENORAY CO., LTD.VETERA PRIME2025-12-01
08809244060625GenorayGENORAY CO., LTD.VETERA CLASSIC2025-12-01
08809244060700GenorayGENORAY CO., LTD.VETERA TURBO2025-12-01
08055186671096FUJIFILM Healthcare Americas CorporationA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLPersona C HR2025-07-02
08800018422601EXTRON 3DRTECH CorporationEXTRON 32025-06-17
08809244060090GenorayGENORAY CO., LTD.ZEN-2090 Turbo2025-05-02
08053307591070TRIDENTTECHNIX SPA2121 R 20 CS2024-11-06
08053307591087TRIDENTTECHNIX SPA3030 R 20 CS2024-11-06
00884838112292Zenition 90Philips Medical Systems Nederland B.V.Zenition 902024-05-28
00884838094932Zenition 30Philips Medical Systems Nederland B.V.Zenition 302024-04-23
08809244060106GenorayGENORAY CO., LTD.OSCAR Prime2018-08-22
08809244060113GenorayGENORAY CO., LTD.OSCAR Classic2018-08-22
08800018420805EXTRON 5DRTECH CorporationEXTRON 52023-08-24
08800018420904EXTRON 7DRTECH CorporationEXTRON 72023-08-24
EZIEZIEHM80001Ziehm 8000Ziehm Imaging GmbH80002020-03-12
EZIEZIEHMVISIONFD1651Ziehm Vision FDZiehm Imaging GmbHVision FD2020-03-12
08055186670396AMRAD MedicalA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLAgility Plus2022-03-25
08055186670402AMRAD MedicalA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLAgility Plus2022-03-25
08055186670419AMRAD MedicalA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLAgility Plus2022-03-25
08055186670426AMRAD MedicalA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLAgility Plus2022-03-25
08055186670433AMRAD MedicalA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLAgility2022-03-25
08055186670440AMRAD MedicalA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLAgility2022-03-25
08809244060120GenorayGENORAY CO., LTD.ZEN-2090 Turbo2022-03-22
04547410467710FDR CROSSFUJIFILM CORPORATIONDR-XD 30002021-12-28
04547410467857Grid (10x12)FUJIFILM CORPORATIONDR-XD 3000 GRID2530 E2021-12-28
04547410467871Grid (14x17)FUJIFILM CORPORATIONDR-XD 3000 GRID3543 E2021-12-28
04547410467888Grid (17x17)FUJIFILM CORPORATIONDR-XD 3000 GRID4343 E2021-12-28
04547410480641Flat panel sensor holderFUJIFILM CORPORATIONDR-XD 3000 HOLDER2530 E2021-12-28
04547410480658Flat panel sensor holderFUJIFILM CORPORATIONDR-XD 3000 HOLDER3543 E2021-12-28
04547410480665Flat panel sensor holderFUJIFILM CORPORATIONDR-XD 3000 HOLDER4343 E2021-12-28
04547410480672Wireless foot switch kitFUJIFILM CORPORATIONDR-XD 3000 WIRELESS F/S E2021-12-28
04547410480689Monitor cartFUJIFILM CORPORATIONDR-XD 3000MX2021-12-28
04547410480832Wired foot switchFUJIFILM CORPORATIONDR-XD 3000 WIRED F/S E2021-12-28
08055186670334FUJIFILM Healthcare Americas CorporationA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLPersona C2021-10-24
08055186670341FUJIFILM Healthcare Americas CorporationA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLPersona C2021-10-24
08055186670358FUJIFILM Healthcare Americas CorporationA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLPersona C2021-10-24
08055186670365FUJIFILM Healthcare Americas CorporationA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLPersona C2021-10-24
08055186670372FUJIFILM Healthcare Americas CorporationA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLPersona CS2021-10-24
08055186670389FUJIFILM Healthcare Americas CorporationA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLPersona CS2021-10-24
08055186670112FUJIFILM Medical Systems U.S.A. Inc.A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLPersona C2021-09-20
08055186670129FUJIFILM Medical Systems U.S.A. Inc.A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLPersona C2021-09-20
08055186670136FUJIFILM Medical Systems U.S.A. Inc.A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLPersona C2021-09-20
08055186670143FUJIFILM Medical Systems U.S.A. Inc.A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLPersona C2021-09-20
08055186670211STEPHANIX A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOMNISCOP DReam2021-09-20
08055186670228STEPHANIX A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOMNISCOP DReam2021-09-20
08055186670235STEPHANIX A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOMNISCOP DReam2021-09-20
08055186670242STEPHANIX A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOMNISCOP DReam2021-09-20
08055186670297STEPHANIXA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOMNISCOP Dream-S2021-09-20
08055186670303STEPHANIXA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOMNISCOP Dream-S2021-09-20
08055186670310FUJIFILM Medical Systems U.S.A. Inc.A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLPersona CS2021-09-20
08055186670327FUJIFILM Medical Systems U.S.A. Inc.A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLPersona CS2021-09-20
00195278096944OECOEC MEDICAL SYSTEMS, INC.3D2021-04-15
00850003909004Smart-CTURNER IMAGING SYSTEMSSmart-C Mini C-Arm Imaging System2020-07-16
00850003909011Smart-CTURNER IMAGING SYSTEMSSupport Stand for Smart-C2020-07-16
00850003909028Smart-CTURNER IMAGING SYSTEMSMonitor Cart for Smart-C2020-07-16
EZIEZIEHMSOLO1Ziehm SoloZiehm Imaging GmbHSolo2016-09-23
EZIEZIEHMSOLOFD1Ziehm Solo FDZiehm Imaging GmbHSolo FD2016-11-17
EZIEZIEHMVISION1Ziehm Vision2Ziehm Imaging GmbH303552016-09-23
EZIEZIEHMVISIONFD1Ziehm Vision2 FDZiehm Imaging GmbH302082016-09-23