FDA.reportPublic FDA data

Basic x-ray clinical assessment support software

Definition
A software program intended to display, analyse/process, and possibly acquire static two-dimensional (2-D) x-ray images of bones and/or the abdominothoracic region, acquired by a basic diagnostic x-ray system, to support a healthcare provider with clinical assessment (e.g., diagnosis, triage, image quality assessment) of a trauma or condition (typically orthopaedic, cardiac or pulmonary). It is not dedicated to treatment planning and does not incorporate adaptive/dynamic machine learning (ML) models.
GUDID devices
119
Last updated
2026-09-04 23:13:36

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
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
00851800007016TigerViewTELEVERE SYSTEMS, LLC8.1 Build 812016-09-27
00851800007047VisixTELEVERE SYSTEMS, LLC7.7.152016-09-27
00851800007061TigerViewTELEVERE SYSTEMS, LLC8.32018-06-22
00851800007108TigerViewTELEVERE SYSTEMS, LLC8.4.12021-10-01
00851800007139TigerViewTELEVERE SYSTEMS, LLC8.62026-05-09
00858012005007SecondLook Digital (SLD)Icad, Inc.V7.22014-09-22
00858012005014PowerLook AMP SLD GE USIcad, Inc.V7.22014-09-22
00858012005021PowerLook AMP SLD GE DirectIcad, Inc.V7.22014-09-22
00858012005038PowerLook AMP SLD SiemensIcad, Inc.V7.22014-09-22
00858012005045PowerLook AMP SLD FujiIcad, Inc.V7.22014-09-22
00858012005052PowerLook AMP SLD HologicIcad, Inc.V7.22014-09-22
00858012005069PowerLook AMP SLD PhilipsIcad, Inc.V7.22014-09-22
00858012005076PowerLook AMP SLD FRUIcad, Inc.V7.22014-09-22
00858012005083PowerLook AMP SLD FRU GEIcad, Inc.V7.22014-09-22
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
00858012005205iReveal Breast Density AssessmentIcad, Inc.V2.12016-09-23
00858012005212PowerLook Tomo Detection SoftwareIcad, Inc.V1.12017-04-03
00858012005229PowerLook PRO Tomo Detection and SLD, GEIcad, Inc.V1.12017-04-03
00858012005236PowerLook PRO Tomo Detection and SLD, GEIcad, Inc.V1.12021-05-17
00858012005243PowerLook PRO with Tomo Detection, Upgrade, GEIcad, Inc.V1.12017-04-03
00858012005250PowerLook PRO Tomo Detection and SLD, GEIcad, Inc.V1.12021-05-17
00858012005267PowerLook PRO Tomo Detection FRUIcad, Inc.V1.12017-04-03
00858012005601PowerLook AMP PRO with SecondLook DigitalIcad, Inc.V7.22016-09-20
00858012005656iReveal with PowerLook AMPIcad, Inc.V2.12016-10-07
00858012005663PowerLook Tomo Detection and SecondLook Digital LicenseIcad, Inc.V1.12017-04-03
00858012005793Powerlook PRO Hardware Upgrade, SLDIcad, Inc.V7.22017-04-03
00858012005809Powerlook PRO Hardware Upgrade, SLDIcad, Inc.V7.22021-05-17
00858012005816PowerLook to PowerLook PRO Upgrade, USIcad, Inc.V7.22017-04-03
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
00858012005854Powerlook PRO with SLD, GE, USIcad, Inc.V7.22017-04-03
00858012005861Powerlook PRO with SLD, FRUIcad, Inc.V7.22017-04-03
00858012005878PowerLook PRO with Tomo DetectionIcad, Inc.V1.12017-04-03
00858012005922PowerLook Density Assessment V3.4Icad, Inc.V3.42018-07-06
00858012005939PowerLook Tomo Detection (ProFound AI)Icad, Inc.V22018-12-27
00858012005960ProFound AIIcad, Inc.2.12019-07-11
03663999000023sterEOS®EOS IMAGINGWorkstation 1.62016-09-21
03663999000030sterEOS®EOS IMAGINGSoftware 1.62016-09-21
03663999000047sterEOS®EOS IMAGINGWorkstation 1.82016-09-21
03663999000054sterEOS®EOS IMAGINGSoftware 1.82016-09-21
03663999000153sterEOSEOS IMAGING1.102024-02-14
03663999000290VEA AlignEOS IMAGING1.02024-05-29
03663999000337VEA AlignEOS IMAGING2.12024-07-05
03663999000412VEA AlignEOS IMAGING3.x2025-08-01
03663999000429VEA AlignEOS IMAGING4.x2026-06-12
03663999000436AutoDensityEOS IMAGING1.32025-12-09
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
04056869124162syngo Application SoftwareSiemens Healthcare GmbH113276672020-01-10
04056869164311syngo.InterventionalSiemens Healthcare GmbH113277472018-08-01
04056869248653syngo.InterventionalSiemens Healthcare GmbH113279882020-01-13
04056869262567syngo Application SoftwareSiemens Healthcare GmbH113281802022-10-10
04056869964539syngo Application SoftwareSiemens Healthcare GmbH300002672024-11-15
04056869964546syngo Application SoftwareSiemens Healthcare GmbH300002662024-01-01
04056869991771myAblation GuideSiemens Healthcare GmbH108313732026-05-11
04068151018226syngo Application SoftwareSiemens Healthcare GmbH118312342026-05-15
04068151027273myAblation GuideSiemens Healthcare GmbH108314052026-08-06
04250802900404dicomPACS®DX-ROehm und Rehbein GmbH4.32017-03-22
04260729622006VELYS Traumametamorphosis GmbH10.037.0012025-12-01
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