FDA.reportPublic FDA data

Diagnostic x-ray digital imaging system workstation application software

Definition
An individual software application program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities to a diagnostic x-ray system workstation so that it may function according to its intended purpose, e.g., for the rendering, visualization and manipulation of medical images to support the image display needs of clinicians, diagnosticians and technicians. A basic set of applications programs and routines are included with the multi-purpose diagnostic x-ray system workstation and can be upgraded to correct programming errors or to add new system capabilities.
GUDID devices
153
Last updated
2026-09-04 23:12:44

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04250802900015dicomPACS®DX-ROehm und Rehbein GmbH82023-12-13
04250802900411dicomPACS®DX-ROehm und Rehbein GmbH52018-12-05
00850073646007TrackXTrackX Technology, LLCTrackX Home Base Pin - 6mm x 100mm2025-07-24
00850073646014TrackXTrackX Technology, LLCTrackX Home Base Pin - 6mm x 150mm2025-07-24
00850073646045TrackXTrackX Technology, LLCTrackX NV RETRACT-ADAPT2025-10-24
00850073646052TrackXTrackX Technology, LLCHome Base Pin Snap2025-10-24
00850073646069TrackXTrackX Technology, LLCInitial Dilator Snap2025-10-24
00850073646076TrackXTrackX Technology, LLCCobb Snap2025-10-24
00850073646083TrackXTrackX Technology, LLCT-Handle Snap2025-10-24
00850073646106TrackXTrackX Technology, LLCTrackX SE RETRACT ADAPT 2-BLADE - MJF VS2026-02-24
00850073646113TrackXTrackX Technology, LLCTrackX AWLSHIDI2025-10-15
00850073646120TrackXTrackX Technology, LLCTrackX AT INSERT-ADAPT 2 - MJF VS2026-04-08
00857088008042TrackXTrackX Technology, LLCVISION-T SNAP2018-10-09
00857088008080TrackXTrackX Technology, LLCVISION™-V SNAP2019-12-04
00857088008684TrackXTrackX Technology, LLCTrackX Insight Base - DS Disc Prep2026-05-11
00860099000882TrackXTrackX Technology, LLCHANG-TEN SNAP2018-08-29
00884838124301LumiGuidePhilips Medical Systems Nederland B.V.LumiGuide Equipment2025-11-19
03665587000187MEDWSMED.E.COMWS.7.72026-05-21
04560141947719KONICAMINOLTA DI-X1KONICA MINOLTA, INC.AD1D2026-03-25
00850073646144TrackXTrackX Technology, LLCACCESS-CALIBRATOR CUP 3 - MJF VS2026-05-26
08801643467098NASamsung Electronics Co., Ltd.Auto Lung Nodule Detection2026-03-17
04056869299297MAMMOVISTA B.smartSiemens Healthcare GmbHVB72026-01-16
00857088008844TrackXTrackX Technology, LLCTrackX AT INSERT-ADAPT2025-12-08
03665587000156MEDWSMED.E.COM7.52025-11-20
03665587000163MEDWSMED.E.COM7.62025-11-20
06970569091006Digital Radiographic Imaging Acquisition Software - DR (RiasDR)iRay GroupRiasDR2025-08-26
04250802900183dicomPACS® Oehm und Rehbein GmbH122025-08-18
00850073646038TrackXTrackX Technology, LLCTrackX Modular Malleting Adapter2025-05-16
04560141951426CS-7KONICA MINOLTA, INC.AEVE2025-04-14
03665587000149MEDWSMED.E.COM7.42025-03-27
03665587000019MEDWSMED.E.COM4.142019-02-15
04262459510028MammoScapeMeVis BreastCare GmbH & Co. KG1.1.x2025-03-04
04560141951914KONICAMINOLTA DI-X1KONICA MINOLTA, INC.AEYC2024-10-07
00857088008875TrackXTrackX Technology, LLCTrackX SE RETRACT-ADAPT 5L - MJF VS2025-02-07
00857088008943TrackXTrackX Technology, LLCTrackX HOME BASE VS SNAP2025-02-07
00857088008271TrackXTrackX Technology, LLCINSIGHT™ ARRAY-ORANGE2020-11-04
00857088008288TrackXTrackX Technology, LLCINSIGHT™ BASE-62020-11-04
00857088008332TrackXTrackX Technology, LLCINSIGHT™ BASE-7L2021-05-28
00857088008349TrackXTrackX Technology, LLCINSIGHT™ ARRAY-GREEN2021-05-28
04560141951419CS-7KONICA MINOLTA, INC.AEVD2024-12-06
04262459510011MammoScapeMeVis BreastCare GmbH & Co. KG1.0.x2024-11-07
00857088008752TrackXTrackX Technology, LLCTrackX Hudson T-Handle2024-10-09
00857088008776TrackXTrackX Technology, LLC"TrackX 1/4"" Square T-Handle"2024-10-09
00857088008783TrackXTrackX Technology, LLCTrackX Hudson MOD T-Handle2024-10-09
00857088008851TrackXTrackX Technology, LLCTrackX SE RETRACT-ADAPT 6.5L - MJF VS2024-10-09
00857088008660TrackXTrackX Technology, LLCTrackX NV INSERT-ADAPT2024-09-12
00857088008745TrackXTrackX Technology, LLCACCESS-CALIBRATOR CUP 22024-09-12
00857088008806TrackXTrackX Technology, LLCTrackX Insight Base - NV/AT Disc Prep2024-09-12
00857088008790TrackXTrackX Technology, LLCACCESS-CALIBRATOR CUP 12024-08-15
00857088008820TrackXTrackX Technology, LLCTrackX AT INSERT-ADAPT - MJF VS2024-08-15
00195174099452LGLG Electronics Inc.ASHK100G2024-07-25
00857088008813TrackXTrackX Technology, LLCTrackX NV RETRACT-ADAPT - MJF VS2024-07-08
00857088008691TrackXTrackX Technology, LLCTrackX Insight Base - DS Disc Prep - MJF VS2024-06-13
00857088008622TrackXTrackX Technology, LLCHex Pin 6mm x 150mm2024-05-28
00857088008707TrackXTrackX Technology, LLCHex Pin 6mm x 100mm2024-05-28
00857088008738TrackXTrackX Technology, LLCACUITY NEEDLE - 15 DIAMOND - 3.2 INNER2024-05-28
00857088008714TrackXTrackX Technology, LLCINSIGHT™ ARRAY-VIOLET2024-04-30
00857088008769TrackXTrackX Technology, LLCASC PROCEDURE KIT 12024-03-19
00857088008653TrackXTrackX Technology, LLCTrackX Insight Base - NV/AT Disc Prep - MJF VS2024-03-13
00857088008646TrackXTrackX Technology, LLCTrackX Insight Base - NV/AT Disc Prep - MJF2024-02-15
00857088008615TrackXTrackX Technology, LLCTrackX NV RETRACT-ADAPT2024-02-08
00860008443717Xoran WorkstationXORAN TECHNOLOGIES LLCv.52024-01-18
00857088008554TrackXTrackX Technology, LLCDilator2023-12-15
00857088008677TrackXTrackX Technology, LLCTrackX PE ADAPT - MJF VS2023-12-13
00857088008561TrackXTrackX Technology, LLC"TrackX 1/4"" EXT-ADAPT"2023-10-30
00884838112087LumiGuidePhilips Medical Systems Nederland B.V.LumiGuide Equipment2023-09-18
00195278584441Quality Care SuiteGE Medical Systems, L.L.C.2.02023-01-24
00857088008455TrackXTrackX Technology, LLC31 cm Flat Panel Collar Assembly2023-09-06
00857088008462TrackXTrackX Technology, LLC31 cm Flat Panel Cap Assembly2023-09-06
00857088008479TrackXTrackX Technology, LLC21 cm Flat Panel Collar Assembly2023-09-06
00857088008486TrackXTrackX Technology, LLC21 cm Flat Panel Cap Assembly2023-09-06
00857088008523TrackXTrackX Technology, LLCTrackX T-ADAPT - PEEK2023-09-06
00857088008585TrackXTrackX Technology, LLCTrackX T-ADAPT - MJF2023-09-06
00857088008608TrackXTrackX Technology, LLCTrackX NV RETRACT-ADAPT - MJF VS2023-09-06
00857088008547TrackXTrackX Technology, LLCACCESS 21-ADAPT2023-08-17
00857088008530TrackXTrackX Technology, LLCTrackX PE ADAPT2023-06-15
04560141950849KONICAMINOLTA DI-X1KONICA MINOLTA, INC.AE9A2023-05-04
00857088008516TrackXTrackX Technology, LLCREVOLVE BASE-NAVIGATOR2023-03-02
00857088008493TrackXTrackX Technology, LLCINSIGHT™ BASE FLEX-82023-03-01
D764B10301910CDR DICOMSIRONA DENTAL, INC.B10301912016-09-09