FDA.reportPublic FDA data

Radiology DICOM image processing application software

Definition
A software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).
GUDID devices
255
Last updated
2026-06-17 06:05:13

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
09421904268029VolparaDensityLUNIT INTERNATIONAL LIMITED3.22016-04-22
09421904268036VolparaDoseRTLUNIT INTERNATIONAL LIMITED3.22016-04-22
09421904268043VolparaDoseSRLUNIT INTERNATIONAL LIMITED3.22016-04-22
09421904268050Volpara Density MapLUNIT INTERNATIONAL LIMITED3.22016-04-22
09421904268074VolparaServerLUNIT INTERNATIONAL LIMITED1.32016-04-22
09421904268098VolparaDensityLUNIT INTERNATIONAL LIMITED3.32017-08-16
09421904268104VolparaDoseRTLUNIT INTERNATIONAL LIMITED3.32017-08-16
09421904268128Volpara Density MapLUNIT INTERNATIONAL LIMITED3.32017-08-16
09421904268166VolparaDensityLUNIT INTERNATIONAL LIMITED3.4.12018-12-18
09421904268265VolparaDoseRTLUNIT INTERNATIONAL LIMITED3.4.22020-09-24
09421904268272VolparaDoseSRLUNIT INTERNATIONAL LIMITED3.4.22020-09-24
09421904268296VolparaDoseRTLUNIT INTERNATIONAL LIMITED4.02020-09-24
09421904268302VolparaDoseSRLUNIT INTERNATIONAL LIMITED4.02020-09-24
08437021468212QP-ProstateQUIBIM SOCIEDAD LIMITADA.1.72026-06-05
08800086200026Veuron-Brain-pAbHeuron Co., Ltd.V-B-pAb-012021-11-09
08800086200064Veuron-Brain-pAb2Heuron Co., Ltd.V-B-pAb-022022-02-18
08800086200408Veuron-Brain-pAb3Heuron Co., Ltd.AD-AWC032024-02-29
G140ANNALISECONTAINER70Annalise TriageHARRISON-AI MEDICAL PTY LTD2.3+2025-07-02
G140ANNALISEENTP20Annalise EnterpriseHARRISON-AI MEDICAL PTY LTD3.2.02023-06-08
G140ANNALISEENTP30Annalise EnterpriseHARRISON-AI MEDICAL PTY LTD3.3.02023-07-24
G140ANNALISEENTP40Annalise TriageHARRISON-AI MEDICAL PTY LTD3.4.12023-11-06
04987670102493Vitrea Software Toshiba PackageCANON INC.VSTP-001A2018-03-02
00199874323862NeuroICHNEUROCAREAI INCV1.1.672026-04-24
00810111225663X-ray AppTreace Medical Concepts, Inc.12-000012026-05-01
00811852030134Viz LVOVIZ.AI, INC.1.92020-01-14
00811852030141Viz CTPVIZ.AI, INC.1.42020-03-05
00860000171229SubtleSYNTHSubtle Medical, Inc.1.x2026-04-09
00860000171236SubtleALIGNSubtle Medical, Inc.1.x2026-04-09
00860000171243SubtleHD(MR)Subtle Medical, Inc.1.x2026-04-09
00860000171298AiMIFYSubtle Medical, Inc.1.x2026-04-09
00860004785118Bullsai® IdentifyTuring Medical Technologies Incv22024-12-16
00860005876891Us2.caEKO.AI PTE. LTD.12026-04-20
00860010267103DeepContourWisdom Technologies, IncV1.02026-04-22
00862611000363ImagenQCARDIOVASCULAR IMAGING TECHNOLOGIES L.L.C.3.02025-10-31
00884838128835NM SuitePhilips Medical Systems Nederland B.V.NM Suite - 152025-10-29
03760262480053EndoNaut (Server) SWTHERENVA1.x.x2026-05-06
03760262480091EndoNaut Server Main Display SWTHERENVA1.x.x2026-05-06
04068151033977AI-Rad companion Brain MRSiemens Healthcare GmbH118304812026-04-14
04260495883120mintLesion™Mint Medical GmbH3.12.02026-04-02
05060896890005GIQuantMOTILENT LIMITED1.5.52026-05-11
05430002070148FEopsFEops4.2.02026-05-21
06430070845029cNeuro cDATCombinostics Oy22026-05-06
06973127400012AccuContourManteia Technologies Co.,Ltd.1.1.02020-06-22
06973127400098AccuContourManteia Technologies Co.,Ltd.4.02026-04-27
06973127400135ARTAssistantManteia Technologies Co.,Ltd.1.12026-04-22
07290019703006CEPHX- CEPHALOMETRIC ANALYSIS SOFTWAREORCA DENTAL AI LTD4.22026-05-14
07290019703013CEPHX3DORCA DENTAL AI LTD1.002026-05-14
07332747225501DTX Studio™ ClinicNobel Biocare AB4.72025-10-06
07332747225518DTX Studio™ ClinicNobel Biocare AB4.72025-10-06
07332747236620DTX Studio™ ClinicNobel Biocare AB4.82026-03-27
07332747236637DTX Studio™ ClinicNobel Biocare AB4.82026-03-27
07613336231098Opulus Lymphoma PrecisionRoche Molecular Systems, Inc.102578730012026-05-08
08056304455864Caas QardiaPie Medical Imaging B.V.2.22026-04-03
08437021468045QP-Brain®QUIBIM SOCIEDAD LIMITADA.1.02026-05-06
08437021468175QP-ProstateQUIBIM SOCIEDAD LIMITADA.1.62025-07-04
08719326703824LungQ®Thirona B.V.LungQ 42026-02-12
08800066200589JLK-ICHJLK, Inc.V1.0.0.02026-03-25
08800066200596JLK-LVOJLK, Inc.V1.0.0.02026-03-25
08800066200602JLK-SDHJLK, Inc.V1.0.0.02026-03-25
08800066200619JLK-AILINKJLK, Inc.V1.0.0.02026-03-25
08800066200626MEDIHUB PROSTATEJLK, Inc.V1.0.0.02026-03-25
08800066200787JLK-CTPJLK, Inc.V1.0.0.02026-03-25
08800066200794JLK-PWIJLK, Inc.V1.0.0.02026-03-25
08800124700129SwiftSight-BrainAIRS Medical Inc.SS25-BR-CL2025-09-30
08800124700136SwiftMRAIRS Medical Inc.A20-CL v3.1.X.X2026-04-01
08800130400303Neurophet AQUA AD PlusNEUROPHET Inc.3.02026-02-24
B319IBFTBX20IB FTB ExpressIMAGING BIOMETRICS, LLC2.02026-04-22
B319LSN1LSNIMAGING BIOMETRICS, LLC12026-04-14
B319QSM1QSMetricIMAGING BIOMETRICS, LLC12026-04-22
B319SC11StoneCheckerIMAGING BIOMETRICS, LLC1.12026-04-14
B621ICOBRAINARIA1X2Y0icobrain ariaicometrix NV1.22025-10-24
CARDIACCHAMBERSMR1TeraRecon Cardiac.Chambers.MRTerarecon Inc.Cardiac.Chambers.MR012024-12-16
SURGICALAR0SurgicalARMEDIVIS, INC1.1.0.02020-11-13
08800130400228Neurophet SCALE PETNEUROPHET Inc.2.02026-05-26
08800130400310Neurophet AQUANEUROPHET Inc.3.22026-05-26
04068151020076syngo DynamicsSiemens Healthcare GmbH117081242026-03-19
08800018412008EConsole2DRTECH CorporationEConsole22026-03-17
EPIS960010EpisurfViewEpisurf Operations AB1.02026-03-17
03665786000018Sim&SizeSIM&CUREv2.12026-03-13
09358140000079Quicktome Software SuiteOmniscient Neurotechnology Pty Ltd (o8t)2.32026-03-09