FDA.report

Basic diagnostic x-ray system application software

Definition
An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a general-purpose x-ray imaging system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software routines or groups of routine packages must be combined with specific hardware or firmware accessories or configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.
GUDID devices
103
Last updated
2025-12-17 15:30:39

Related Product Codes

CodeDeviceSpecialtyClassDevices
LLZSystem, Image Processing, RadiologicalRadiology254
MYNAnalyzer, Medical ImageRadiology235
QIHAutomated Radiological Image Processing SoftwareRadiology25
QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For CancerRadiology23
KPRSystem, X-Ray, StationaryRadiology22
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology22
KGIDensitometer, BoneRadiology21
OTEDigital Breast TomosynthesisUnknown31

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
03663999000436AutoDensityEOS IMAGING1.32025-12-09
04260729622006VELYS Traumametamorphosis GmbH10.037.0012025-12-01
03663999000412VEA AlignEOS IMAGING3.x2025-08-01
B214OSTBSIV400TBS iNsightmedimaps group SA4.02025-02-13
04056869964539syngo Application SoftwareSiemens Healthcare GmbH300002672024-11-15
04560141951433Bone Suppression SoftwareKONICA MINOLTA, INC.AEVM2024-07-08
03663999000337VEA AlignEOS IMAGING2.12024-07-05
03663999000290VEA AlignEOS IMAGING1.02024-05-29
04056869964546syngo Application SoftwareSiemens Healthcare GmbH300002662024-01-01
08809413810679ExamVue JPI HEALTHCARE. CO., LTD.ExamVue Duo2023-06-15
04056869262567syngo Application SoftwareSiemens Healthcare GmbH113281802022-10-10
00851800007108TigerViewTELEVERE SYSTEMS, LLC8.4.12021-10-01
00850008977176ProFound AI V3.0Icad, Inc.3.02021-05-17
00850008977183PowerLook AMP with Density Assessment GE USIcad, Inc.DSC012-022021-05-17
00850008977190PowerLook AMP with Density Assessment GE OUSIcad, Inc.DSC012-032021-05-17
00858012005090PowerLook AMP SLD GE OUSIcad, Inc.DSC010-01-EU2021-05-17
00858012005106PowerLook AMP SLD GE OUS DirectIcad, Inc.DSC010-12-EU2021-05-17
00858012005113PowerLook AMP SLD Siemens OUSIcad, Inc.DSC010-03-EU2021-05-17
00858012005120PowerLook AMP SLD Fuji OUSIcad, Inc.DSC010-04-EU2021-05-17
00858012005137PowerLook AMP SLD Hologic OUSIcad, Inc.DSC010-05-EU2021-05-17
00858012005144PowerLook AMP SLD GiottoIcad, Inc.DSC010-062021-05-17
00858012005151PowerLook AMP SLD Philips OUSIcad, Inc.DSC010-07-EU2021-05-17
00858012005168PowerLook AMP SLD PlanmedIcad, Inc.DSC010-082021-05-17
00858012005175PowerLook AMP SLD Agfa CRIcad, Inc.DSC010-092021-05-17
00858012005236PowerLook PRO Tomo Detection and SLD, GEIcad, Inc.V1.12021-05-17
00858012005250PowerLook PRO Tomo Detection and SLD, GEIcad, Inc.V1.12021-05-17
00858012005809Powerlook PRO Hardware Upgrade, SLDIcad, Inc.V7.22021-05-17
00858012005823Powerlook PRO Hardware Upgrade, SLDIcad, Inc.V7.22021-05-17
00858012005830PowerLook AMP PRO, SLD, GE, ROWIcad, Inc.V7.22021-05-17
00858012005847PowerLook AMP PRO, SLD, GE, ROWIcad, Inc.V7.22021-05-17
08800011170004DRGEMDRGEM CorporationRADMAX2019-03-12
08800018600580Xmaru ProRayence Co., Ltd.Xmaru Pro2020-07-24
08800018600597Xmaru PodviewRayence Co., Ltd.Xmaru Podview2020-07-24
08800018600603Xmaru ChiroviewRayence Co., Ltd.Xmaru Chiroview2020-07-24
08800018600610XmaruView V1Rayence Co., Ltd.XmaruView V12020-07-24
08809413810471Box for ExamVue PACS(outside 265mmx185mmx150mm)JPI HEALTHCARE. CO., LTD.ExamVue PACS2020-04-10
08809413810488Box for ExamVue DR(outside 265mmx185mmx150mm)JPI HEALTHCARE. CO., LTD.ExamVue DR2020-04-10
04056869248653syngo.InterventionalSiemens Healthcare GmbH113279882020-01-13
04056869124162syngo Application SoftwareSiemens Healthcare GmbH113276672020-01-10
08800011130008DRGEMDRGEM CorporationRADMAX2019-03-12
00858012005960ProFound AIIcad, Inc.2.12019-07-11
15420045500020Selenia Dimensions C-View SoftwareHologic, Inc.C-View2014-09-05
60889971029881DRX - Ascend SystemCARESTREAM HEALTH, INC.DRX - Ascend System2017-07-24
04056869012902syngo Application SoftwareSiemens Healthcare GmbH108491242016-09-24
04056869020501syngo.InterventionalSiemens Healthcare GmbH108491372016-09-24
04056869020518syngo.InterventionalSiemens Healthcare GmbH108491382016-09-24
04056869025902syngo Application Software MediaSiemens Healthcare GmbH108491162016-09-24
04056869025919syngo Application Software KITSiemens Healthcare GmbH108491122016-09-24
04056869026305syngo.InterventionalSiemens Healthcare GmbH108491692017-10-15
04056869050874syngo Application SoftwareSiemens Healthcare GmbH108492312017-04-10
04056869164311syngo.InterventionalSiemens Healthcare GmbH113277472018-08-01
04250802900404dicomPACS®DX-ROehm und Rehbein GmbH4.32017-03-22
04548213024698i-DixelJ.MORITA MFG.CORP.i-Dixel2016-09-23
04548213024704i-DixelJ.MORITA MFG.CORP.i-Dixel2016-09-23
04548213024711i-DixelJ.MORITA MFG.CORP.i-Dixel2016-09-23
04548213024728i-DixelJ.MORITA MFG.CORP.i-Dixel2016-09-23
04548213024735i-DixelJ.MORITA MFG.CORP.i-Dixel2016-09-23
04548213025176i-DixelJ.MORITA MFG.CORP.i-Dixel2016-09-09
04548213025183i-DixelJ.MORITA MFG.CORP.i-Dixel2016-09-23
04548213025282i-DixelJ.MORITA MFG.CORP.i-Dixel2016-09-23
04548213025299i-DixelJ.MORITA MFG.CORP.i-Dixel2016-09-23
04548213026760i-DixelJ.MORITA MFG.CORP.i-Dixel2017-02-12
04548213026777i-DixelJ.MORITA MFG.CORP.i-Dixel2017-02-12
04548213026784i-DixelJ.MORITA MFG.CORP.i-Dixel2017-02-12
04548213026791i-DixelJ.MORITA MFG.CORP.i-Dixel2017-02-12
04548213026807i-DixelJ.MORITA MFG.CORP.i-Dixel2017-02-12
04548213026814i-DixelJ.MORITA MFG.CORP.i-Dixel2017-02-12
04548213026821i-DixelJ.MORITA MFG.CORP.i-Dixel2017-02-12
04548213026838i-DixelJ.MORITA MFG.CORP.i-Dixel2017-02-12
04548213026845i-DixelJ.MORITA MFG.CORP.i-Dixel2017-02-12
04548213026852i-DixelJ.MORITA MFG.CORP.i-Dixel2017-02-12
04548213026944i-DixelJ.MORITA MFG.CORP.i-Dixel2017-02-12
04548213026951i-DixelJ.MORITA MFG.CORP.i-Dixel2017-02-12
04548213026968i-DixelJ.MORITA MFG.CORP.i-Dixel2017-02-12
04548213026975i-DixelJ.MORITA MFG.CORP.i-Dixel2017-02-12
04548213026982i-DixelJ.MORITA MFG.CORP.i-Dixel2017-02-12
00851800007016TigerViewTELEVERE SYSTEMS, LLC8.1 Build 812016-09-27
00851800007047VisixTELEVERE SYSTEMS, LLC7.7.152016-09-27
00851800007061TigerViewTELEVERE SYSTEMS, LLC8.32018-06-22
00858012005007SecondLook Digital (SLD)Icad, Inc.V7.22014-09-22