FDA.reportPublic FDA data

Stationary general-purpose fluoroscopic x-ray system, digital

Definition
A stationary general-purpose diagnostic fluoroscopic x-ray system that uses real-time digital techniques for image capture, display and manipulation and is specifically designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging. 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 viewed in both real-time and delayed format.
GUDID devices
96
Last updated
2026-06-18 06:05:15

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04056869993973LUMINOS Q.namix RSiemens Healthcare GmbH115740022025-07-30
04056869993980LUMINOS Q.namix TSiemens Healthcare GmbH115740032025-07-30
04056869009179Multitom RaxSiemens Healthcare GmbH108607002016-09-24
05713464000862Adora DRFiNrt - Nordisk Røntgen Teknik A/S045500102025-09-16
08057737120114Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAApollo DRF2016-09-24
08057737120312Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAApollo EZ DRF2016-09-24
08057737120411Philips Medical Systems DMCVILLA SISTEMI MEDICALI SPAJuno DRF2016-09-24
08809365283033SG HealthcareSG Healthcare Co., Ltd.Garion2026-04-24
03664049000017STEPHANIXSTEPHANIXD2RS2016-10-22
03664049000024STEPHANIXSTEPHANIXD2RS_AT2016-10-22
04540217040872SONIALVISION G4SHIMADZU CORPORATION503-78000-512019-08-14
04540217040889SONIALVISION G4SHIMADZU CORPORATION503-78000-522019-08-14
04540217040896SONIALVISION G4SHIMADZU CORPORATION503-78000-532019-08-14
04540217041022SONIALVISION G4SHIMADZU CORPORATION566-10000-412019-08-14
04540217041039SONIALVISION G4SHIMADZU CORPORATION566-10000-422019-08-14
04540217041046SONIALVISION G4SHIMADZU CORPORATION566-10000-432019-08-14
04540217041053SONIALVISION G4SHIMADZU CORPORATION566-10000-462019-08-14
04540217041060SONIALVISION G4SHIMADZU CORPORATION566-10000-472019-08-14
08053307590196NAUTILUSTECHNIX SPANAUTILUS2024-11-06
06973031299511 Image Processing UnitGuangdong Optomedic Technologies, Inc.71-068-05 NIR-CA2024-04-22
06973031299528Light SourceGuangdong Optomedic Technologies, Inc.71-182-30 NIR-CA2024-04-22
06973031299825FloNavi Camera HeadGuangdong Optomedic Technologies, Inc.OPTO-CHD21002024-03-26
06973031299832Image Processing UnitGuangdong Optomedic Technologies, Inc.OPTO-CAM21002024-03-26
06973031299962FloNavi Light SourceGuangdong Optomedic Technologies, Inc.OPTO-LED21002024-03-25
06973031299672FloNavi Light SourceGuangdong Optomedic Technologies, Inc.OPTO-LED214K2023-11-14
06973031299955 Image Processing UnitGuangdong Optomedic Technologies, Inc.OPTO-CAM214K2023-11-14
06973031299702 VEQTRON Guangdong Optomedic Technologies, Inc.71-068-05 NIR2023-11-11
06973031299719VEQTRON Guangdong Optomedic Technologies, Inc.71-182-30 NIR2023-11-11
06973031299795AMNOTECAMNOTEC International Medical GmbH71-146-30 NIR C-US2023-08-18
06973031299924AMNOTECAMNOTEC International Medical GmbH71-182-30 NIR2023-08-18
03664049000031STEPHANIXSTEPHANIXD2RS_B1_N2023-06-05
03664049000048STEPHANIXSTEPHANIXD2RS_AT_PA2023-06-05
03664049000055STEPHANIXSTEPHANIXD2RS_B1_NV22023-06-05
03664049000062STEPHANIXSTEPHANIXD2RS_AT_PA_NV22023-06-05
03664049001038STEPHANIXSTEPHANIXD2RS_9090_B1_N2023-06-05
03664049001045STEPHANIXSTEPHANIXD2RS_9090_AT_PA2023-06-05
03664049001052STEPHANIXSTEPHANIXD2RS_9090_B1_NV22023-06-05
03664049001069STEPHANIXSTEPHANIXD2RS_9090_AT_PA_NV22023-06-05
04250941997013AMNOTECAMNOTEC International Medical GmbH71-088-20 NIR2023-06-05
04250941997020AMNOTECAMNOTEC International Medical GmbH71-088-23 NIR2023-06-05
04250941997037AMNOTECAMNOTEC International Medical GmbH71-088-27 NIR2023-06-05
04250941997044AMNOTECAMNOTEC International Medical GmbH71-089-30 NIR2023-06-05
04250942101419AMNOTECAMNOTEC International Medical GmbH71-068-10 NIR2023-06-05
04250942104519AMNOTECAMNOTEC International Medical GmbH71-182-30 NIR2023-06-05
04250942120601AMNOTECAMNOTEC International Medical GmbH71-146-30 NIR C-US2023-06-05
04250942101402AMNOTECAMNOTEC International Medical GmbH71-068-05 NIR2023-06-01
00884838110588Precision CRFPhilips Medical Systems DMC GmbH7064002023-02-14
00884838103221ProxiDiagnost N90Philips Medical Systems DMC GmbH7061102022-01-17
04540217065271FLUOROspeedSHIMADZU CORPORATION566-23000-032021-08-20
B475FBLM0FLUOBEAM LMFLUOPTICSFBLM2021-02-18
B475LXHO0FLUOCLIPFLUOPTICSLXHO2021-02-18
04540217064809SONIALVISION G4SHIMADZU CORPORATION503-78000-242021-01-15
04540217064816SONIALVISION G4SHIMADZU CORPORATION503-78000-542021-01-15
04056869269931LUMINOS Lotus MaxSiemens Healthcare GmbH115741002020-11-01
03701440100035Duet DRFTHALES AVS FRANCE SAS631119762020-10-23
07290012104909ArtPIX DRFC.M.T. MEDICAL TECHNOLOGIES LTD.636275892020-10-18
04540217061723FLUOROspeedSHIMADZU CORPORATION566-23000-022020-07-17
00840682119238PrecisionGE Medical Systems, L.L.C.500D2016-08-01
00840682120982PrecisionGE Medical Systems, L.L.C.600FP2017-08-01
04540217061716FLUOROspeedSHIMADZU CORPORATION566-23000-012019-10-24
B475FBLX0FLUOBEAM LXFLUOPTICSFBLX2019-09-05
08054890480000OPERA SWINGGENERAL MEDICAL MERATE SPAX-RAY R&F REMOTE SYSTEM OPERA SWING2016-09-22
08054890480048OPERA SWINGGENERAL MEDICAL MERATE SPAOPERA D4000RF2016-09-22
08054890480055CLISIS SYSTEMSGENERAL MEDICAL MERATE SPACLISIS SYSTEMS2018-07-11
08054890480079CLISIS SYSTEMSGENERAL MEDICAL MERATE SPAOPERA D4000RF2018-07-11
08054890480109Discovery RF180GENERAL MEDICAL MERATE SPADiscovery RF1802018-07-11
08054890480123Discovery RF180GENERAL MEDICAL MERATE SPAOPERA D4000RF2018-07-11
B475FB800CLV180FLUOBEAM 800FLUOPTICSFB800-CL v1.82017-04-27
B475FB800CLV190FLUOBEAM 800FLUOPTICSFB800-CL v1.92018-06-25
B475FC800CLV180FLUOCASE 800FLUOPTICSFC800-CL v1.82017-04-27
B475FC800CLV190FLUOCASE 800FLUOPTICSFC800-CL v1.92018-06-25
B475FXCLV111FLUOBEAM SYSTEM STORED INTO FLUOBOXFLUOPTICSFX-CL v1.12017-04-27
B475PVUEC0A1V100PHOTONVUEFLUOPTICSPVUEC0A1 V1.02017-04-27
B475PVUEC0A2V100PHOTONVUEFLUOPTICSPVUEC0A2 V1.02017-04-27
B475PVUECCB100PHOTONVUE CONTROL BOXFLUOPTICSPVUECCB-1.02018-01-19
B475PVUECOH100PHOTONVUE OPTICAL HEADFLUOPTICSPVUECOH-1.02018-01-19
B475PVUETSC101Photonvue boxFLUOPTICSPVUE-TSC-1.02018-01-19
04056869009155Luminos dRF MaxSiemens Healthcare GmbH107624712016-09-24
04540217040902SONIALVISON G4SHIMADZU CORPORATION503-78000-212016-09-16
04540217040919SONIALVISON G4SHIMADZU CORPORATION503-78000-222016-09-16