FDA.report

CT system application software

Definition
An application software program intended to add specific image processing and/or analysis capabilities to an x-ray computed tomography (CT) imaging system; it is not dedicated to radiotherapy treatment planning. 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 routines 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
83
Last updated
2026-02-05 16:16:33

Related Product Codes

CodeDeviceSpecialtyClassDevices
JAKSystem, X-Ray, Tomography, ComputedRadiology241
KGIDensitometer, BoneRadiology212
LLZSystem, Image Processing, RadiologicalRadiology212
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat25
MUJSystem, Planning, Radiation Therapy TreatmentRadiology23
QASRadiological Computer-Assisted Triage And Notification SoftwareRadiology23
QIHAutomated Radiological Image Processing SoftwareRadiology23
POKComputer-Assisted Diagnostic Software For Lesions Suspicious For CancerRadiology22
LHNSystem, Radiation Therapy, Charged-Particle, MedicalRadiology21
QKBRadiological Image Processing Software For Radiation TherapyRadiology21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
19356870000038CT:VQ4DMEDICAL LIMITED2.2.02026-01-28
00195278932341Spectral Color OverlayGE MEDICAL SYSTEMS, INC.1.12026-01-26
00195278932358Spectral Bone MarrowGE MEDICAL SYSTEMS, INC.1.12026-01-26
00195278932365Head Auto ViewsGE MEDICAL SYSTEMS, INC.1.12026-01-26
01935687000038CT:VQ4DMEDICAL LIMITED2.2.02025-12-08
00882916000530TruPlanCircle Cardiovascular Imaging Inc3.x2023-01-23
04056869290355syngo.CT CaScoringSiemens Healthcare GmbH115464022025-11-24
04056869959009syngo.via RT Image SuiteSiemens Healthcare GmbH116646182025-11-18
04056869994536syngo.CT Dual EnergySiemens Healthcare GmbH116648072025-04-11
00866854000401X-ray Imaging System (XIS)EhmetDx LLCv.1.x2025-03-21
00882916001025StrokeSENS LVOCircle Cardiovascular Imaging Incv2.x2025-02-05
00195278560384Auto SegmentationGE MEDICAL SYSTEMS, INC.1.02024-11-05
00195278865335SnapShot Freeze 2GE MEDICAL SYSTEMS, INC.1.12024-10-11
19356870000021CT LVAS4DMEDICAL LIMITED1.x2024-06-20
04056869996172AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH116657802024-04-05
04056869964331AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH116654092022-12-21
00195278534064Spine Auto ViewsGE MEDICAL SYSTEMSSee CODE part2024-03-11
04056869267340syngo.CT Dual EnergySiemens Healthcare GmbH115463072023-12-19
04056869966922syngo.CT Dual EnergySiemens Healthcare GmbH115464602023-12-18
00195278629586Head Auto ViewsGE MEDICAL SYSTEMS, INC.1.02023-08-25
00195278630377Spectral Bone MarrowGE MEDICAL SYSTEMS, INC.1.02023-08-25
00195278630384Spectral Color OverlayGE MEDICAL SYSTEMS, INC.1.02023-08-25
00195278620453DLIRGE HEALTHCARE JAPAN CORPORATION1.22023-06-30
04056869297286AI-Rad Companion (Cardiovascular)Siemens Healthcare GmbH115833242023-03-10
04056869267456syngo.CT Brain HemorrhageSiemens Healthcare GmbH115463202022-11-30
04056869287386syngo.CT Extended FunctionalitySiemens Healthcare GmbH115464172022-10-25
04056869287393syngo.via RT Image SuiteSiemens Healthcare GmbH115464182022-10-25
04056869287416syngo.CT ApplicationsSiemens Healthcare GmbH115464302022-10-25
00882916000523TruPlanCircle Cardiovascular Imaging Inc2.12022-10-20
04056869297279AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH115833232022-09-28
00811907031819Lung Image AnalysisPULMONX CORPORATIONLIA-01-0012022-09-05
B926SSSX10StrokeSENSCircle Neurovascular Imaging Incv1.x2022-08-30
00852426007022VIDA InsightsVIDA DIAGNOSTICS, INC.3.x2022-08-04
B745ELUCIDVIVOA3ElucidVivoELUCID BIOIMAGING INC.A.32022-08-01
B816VNC2P30Optellum Virtual Nodule ClinicOPTELLUM LTD2.32022-06-15
10884521214002EmprintCovidien LPCAMPP2016-09-24
10884521214019EmprintCovidien LPCAMPV2016-09-24
B745VASCUCAPA2vascuCAPELUCID BIOIMAGING INC.A.22022-02-17
04056869252230syngo.CT Extended FunctionalitySiemens Healthcare GmbH115461362021-09-21
04056869267425syngo.via RT Image SuiteSiemens Healthcare GmbH115463182021-09-21
04056869267463syngo.CT Skull UnfoldingSiemens Healthcare GmbH115463362021-09-03
00195278303196ASiR-VGE HEALTHCARE JAPAN CORPORATION1.12021-08-25
00195278303202DLIRGE HEALTHCARE JAPAN CORPORATION1.12021-08-25
00195278303219MARGE HEALTHCARE JAPAN CORPORATION1.12021-08-25
00858012005885VeraLook CTC CADIcad, Inc.V1.02021-05-17
00858012005892VeraLook CTC CADIcad, Inc.V1.02021-05-17
00858012005915VeraLook CTC CADIcad, Inc.V1.12021-05-17
B816VNC2P10Optellum Virtual Nodule ClinicOPTELLUM LTD2.1.02021-04-08
04056869251202AI-Rad Companion (Engine)Siemens Healthcare GmbH112700352021-03-09
04056869251226AI-Rad Companion (Cardiovascular)Siemens Healthcare GmbH112700372021-03-09
04056869251219AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH112700362021-03-08
04056869251233AI-Rad Companion (Musculoskeletal)Siemens Healthcare GmbH112700382021-03-08
00882916000516TruPlanCircle Cardiovascular Imaging Inc1.x2021-03-01
19356870000014XV Lung Ventilation Analysis Software4DMEDICAL LIMITEDXV LVAS2021-01-18
10884521214026EmprintCovidien LPCAMPA2016-09-24
00840682134972ASiR-VGE MEDICAL SYSTEMS, INC.1.02017-10-25
00840682134989MARGE MEDICAL SYSTEMS, INC.1.02017-10-25
00840682146586DLIRGE HEALTHCARE JAPAN CORPORATION1.02020-02-21
00852426007015LungPrint VIDA DIAGNOSTICS, INC.1.x2020-04-14
B634SW0121900201060Monarch Software Laptop v2.1.6AURIS HEALTH, INC.Version 2.1.62020-03-05
B634SW0121940202000Monarch Software Laptop v2.2.1AURIS HEALTH, INC.Version 2.2.12020-03-05
B634SW0032760201050Monarch™ Software Laptop v2.1.5AURIS HEALTH, INC.Version 2.1.52019-09-10
00840682142601SnapShot FreezeGE MEDICAL SYSTEMS, INC.22018-09-05
B634SW0032760201040Monarch™ Software Laptop v2.1.4AURIS HEALTH, INC.Version 2.1.42019-05-10
B745A40vascuCAPELUCID BIOIMAGING INC.A.1.22019-04-30
B052DIASYNC0QCT Pro Asynchronous Calibration Module, CliniQCTMINDWAYS SOFTWARE, INC.K1403422017-03-31
B052DICTXAHIP0CTXA Hip Bone Mineral DensitometerMINDWAYS SOFTWARE, INC.K0021132017-03-31
B052DICTXAHIPEXTDB0CTXA Hip Extended Reference DataMINDWAYS SOFTWARE, INC.K0303302017-03-31
B052DIQCTPRO0QCT Bone Mineral Density Analysis SoftwareMINDWAYS SOFTWARE, INC.K8948542017-03-31
B052QCTPROM0AS0QCT PRO Asynchronous 3D Spine SoftwareMINDWAYS SOFTWARE, INC.K894854K1403422017-03-31
B052QCTPROM0ASH0QCT PRO Asynchronous 3D Spine and CTXA-Hip SoftwarMINDWAYS SOFTWARE, INC.K894854K002113K030330K1403422017-03-31
B052QCTPROM0SS0QCT PRO 3D Volumetric Spine SoftwareMINDWAYS SOFTWARE, INC.K8948542017-03-31
B052QCTPROM0SSH0QCT PRO 3D Volumetric Spine and CTXA Hip SoftwareMINDWAYS SOFTWARE, INC.K894854K002113K0303302017-03-31
B052QCTPROM3ASH0QCT PRO Asynchronous 3D Spine and CTXA-Hip SystemMINDWAYS SOFTWARE, INC.K894854K002113K030330K1403422017-03-31
B052QCTPROM3SS0QCT PRO 3D Volumetric Spine SystemMINDWAYS SOFTWARE, INC.K8948542017-03-31
B052QCTPROM3SSH0QCT PRO 3D Volumetric Spine and CTXA Hip SystemMINDWAYS SOFTWARE, INC.K894854K002113K0303302017-03-31
B052QCTPROM4ASH0QCT PRO Asynchronous 3D Spine and CTXA-Hip SystemMINDWAYS SOFTWARE, INC.K894854K002113K030330K1403422017-03-31
B634SW0032760201020Monarch™ Software Laptop v2.1.2AURIS HEALTH, INC.Version 2.1.22018-06-08
B634SW0032760201030Monarch™ Software Laptop v2.1.3AURIS HEALTH, INC.Version 2.1.32018-10-15
07290016836004SafeCTMEDIC VISION - IMAGING SOLUTIONS LTD1.22018-02-01