FDA.reportPublic FDA data

Portable general-purpose fluoroscopic x-ray system, digital

Definition
A portable (moveable from one location to another, and easily reassembled) 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.
GUDID devices
72
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00643169868137O-ARM®MEDTRONIC NAVIGATION, INC.97327212024-04-07
08809244060533GenorayGENORAY CO., LTD.BELLIGER ACE2026-04-10
08809244060557GenorayGENORAY CO., LTD.AREX2026-04-10
08809244060632GenorayGENORAY CO., LTD.VETERA ACE2026-04-10
B225100000220Orthoscan TAU MVP 1515Ziehm-Orthoscan, Inc.1000-00222026-04-30
B225100000230Orthoscan TAU MVP 2020Ziehm-Orthoscan, Inc.1000-00232026-04-30
08809244060601GenorayGENORAY CO., LTD.VETERA FD2025-12-01
00613994462428O-ArmMEDTRONIC NAVIGATION, INC.9733292R2025-11-27
B225100000200Orthoscan Versa Mini C-ArmZiehm-Orthoscan, Inc.1000-00202025-07-11
08809244060465GenorayGENORAY CO., LTD.OSCAR 152025-05-02
00643169618121O-armMEDTRONIC NAVIGATION, INC.BI700020002024-10-10
00763000709631O-armTM O2 Imaging SystemMEDTRONIC NAVIGATION, INC.BI700020002024-08-26
00193982184506EXCELSIUS3DGLOBUS MEDICAL, INC.6161.10002024-06-26
00193982184537EXCELSIUS3DGLOBUS MEDICAL, INC.6161.21002024-06-26
00763000863302O-arm O2MEDTRONIC NAVIGATION, INC.BI700020002024-05-20
04056869279619CIARTIC MoveSiemens Healthcare GmbH111081302024-05-01
00763000616502O-arm O2MEDTRONIC NAVIGATION, INC.BI700020002024-04-28
20643169868131O-ARM®MEDTRONIC NAVIGATION, INC.97327212024-04-07
08809244060021GenorayGENORAY CO., LTD.ZEN-2090 Pro2016-09-24
08809244060083GenorayGENORAY CO., LTD.ZEN-70002016-09-24
08809244060458GenorayGENORAY CO., LTD.OSCAR 15FD2023-11-17
08809244060069GenorayGENORAY CO., LTD.OSCAR 15i2023-07-28
08809244061219GenorayGENORAY CO., LTD.OSCAR 152018-04-11
04056869267180CIOS SELECTSiemens Shanghai Medical Equipment Ltd.115150882023-06-08
00763000528133O-ARM®MEDTRONIC NAVIGATION, INC.BI700020002022-06-02
00763000584115O-ARM®MEDTRONIC NAVIGATION, INC.BI700020002022-05-16
00763000616564O-armMEDTRONIC NAVIGATION, INC.BI700020002022-04-29
08904269405519Skan C Mobile C - Arm X - Ray systemSKANRAY TECHNOLOGIES LIMITEDF303-000187-22019-01-21
00763000542849O-ARM®MEDTRONIC NAVIGATION, INC.BI700020002021-10-21
00763000355579O-ARM®MEDTRONIC NAVIGATION, INC.BI700020002021-07-30
00763000355609O-ARM®MEDTRONIC NAVIGATION, INC.BI700020002021-07-30
B225100000150TAU Model 1000-0015 Mini C-ArmZiehm-Orthoscan, Inc.1000-00152021-05-27
B225100000160TAU Model 1000-0016 Mini C-ArmZiehm-Orthoscan, Inc.1000-00162021-05-27
B225100000170TAU Model 1000-0017 Mini C-ArmZiehm-Orthoscan, Inc.1000-00172021-05-27
04056869246628Cios FlowSiemens Healthcare GmbH111081102021-02-01
00763000355555O-ARM®MEDTRONIC NAVIGATION, INC.BI700020002020-10-16
00643169983021O-ARM®MEDTRONIC NAVIGATION, INC.BI700020002019-07-29
00763000134518O-ARM®MEDTRONIC NAVIGATION, INC.BI700020002020-01-09
00763000074050O-ARM®MEDTRONIC NAVIGATION, INC.BI700020002019-09-20
00613994462442O-arm ™ TrackersMEDTRONIC NAVIGATION, INC.9733302R2019-05-04
15420045505773Flourocsan InSightHologic, Inc.InSight FD2016-08-23
15420045505896InSight 2Hologic, Inc.InSight 22016-08-23
15420045509634Flourocsan InSightHologic, Inc.InSight FD Refresh2018-10-17
15420045509641Flouroscan InSightHologic, Inc.System Software2018-10-17
20643169525874O-ARM®MEDTRONIC NAVIGATION, INC.BI900000482016-08-01
20643169803002O-ARM®MEDTRONIC NAVIGATION, INC.97327212017-08-12
20885074546180O-ARM®MEDTRONIC NAVIGATION, INC.97327212016-09-18
B225100000040OrthoScan HD Mini C-armZiehm-Orthoscan, Inc.1000-00042017-03-07
B22510000004FD0OrthoScan Pulse Mini C-armZiehm-Orthoscan, Inc.1000-0004-FD2017-03-07
B225100000050OrthoScan Mobile DI Mini C-armZiehm-Orthoscan, Inc.1000-00052017-03-07
00613994416209O-ARM®MEDTRONIC NAVIGATION, INC.BI400000152019-03-23
00643169625228O-ARM®MEDTRONIC NAVIGATION, INC.BI700000281202019-03-24
04056869009032Cios AlphaSiemens Healthcare GmbH103081912016-09-24
04056869009056Cios FusionSiemens Healthcare GmbH103081922016-09-24
04056869148243Cios SelectSiemens Shanghai Medical Equipment Ltd.110208062018-09-20
04056869153490Cios AlphaSiemens Healthcare GmbH111052002019-01-10
04056869153506Cios SpinSiemens Healthcare GmbH103081942019-01-10
00763000068066O-ARM®MEDTRONIC NAVIGATION, INC.BI700020002019-01-14
00763000068097O-ARM®MEDTRONIC NAVIGATION, INC.BI700020002018-07-05
00763000132378O-ARM®MEDTRONIC NAVIGATION, INC.BI700020002018-09-23
00643169353428O-ARM®MEDTRONIC NAVIGATION, INC.BI700000281202016-08-01
00643169502611NAMEDTRONIC NAVIGATION, INC.97339282016-08-29
00643169589292O-ARM®MEDTRONIC NAVIGATION, INC.BI70000028120R2016-09-17
00643169639683O-ARM®MEDTRONIC NAVIGATION, INC.BI700020002016-08-01
00643169845091O-ARM®MEDTRONIC NAVIGATION, INC.BI700000281202016-10-31
00643169869844O-ARM®MEDTRONIC NAVIGATION, INC.BI710005472017-01-16
00643169980976O-ARM®MEDTRONIC NAVIGATION, INC.BI700020002018-06-25
00613994245755O-arm ™ TrackersMEDTRONIC NAVIGATION, INC.97333022016-05-27
00613994245762O-arm ™ TrackersMEDTRONIC NAVIGATION, INC.97333012016-05-27
00613994245793O-arm ™ TrackersMEDTRONIC NAVIGATION, INC.97333032016-05-27
00613994245809O-arm ™ TrackersMEDTRONIC NAVIGATION, INC.97332922016-09-29
00613994467126N/AMEDTRONIC NAVIGATION, INC.97339282016-06-19