FDA.reportPublic FDA data

Ultrasound imaging 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 diagnostic ultrasound 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 programs or program packages must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.
GUDID devices
98
Last updated
2026-09-04 23:12:20

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
07540205000397Clarius Ultrasound ScannerClarius Mobile Health CorpApp - iOS2017-04-25
07540205000403Clarius Ultrasound ScannerClarius Mobile Health CorpApp - Android2017-04-25
00195278504302EchoPACGE Vingmed Ultrasound A/SSoftware Only v2062022-08-23
00195278504326EchoPACGE Vingmed Ultrasound A/SPlug-in v2062022-08-23
00860006305734See-Mode TechnologiesSEE-MODE TECHNOLOGIES PTE. LTD.See-Mode Augmented Reporting Tool, Breast (SMART-B2026-08-07
07290019208075UltraSight GuidanceULTRASIGHT LTDV12026-05-25
00860010575314AS SoftwareAs Software, LLCAS Online2026-03-10
00860010575321AS SoftwareAs Software, LLCAsera2026-03-10
G762AISAPCARDIOV10AISAP Cardio V1.0AISAP LTD2.X.Y.Z2026-02-18
00860003552001Focalyx FusionFocalyx Technologies, LLC1.72026-01-02
00884838129771LVivo View SelectionPhilips Ultrasound LLC3.1.0.02025-12-18
00198953079249VscanGE Vingmed Ultrasound A/SAir R3.1 for Android2025-11-17
00198953079256VscanGE Vingmed Ultrasound A/SAir R3.1 for iOS2025-11-17
03770033463031FETOLYDIAGNOLY22025-09-29
00198953038604CaptionGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCGuidance2025-09-15
03770033463024FETOLYDIAGNOLY12025-09-15
00860010575307AS-EMR SYSTEM; AS-OBGYN INFORMATION SYSTEMAs Software, LLC102023-07-13
00195278951700EchoPACGE Vingmed Ultrasound A/SSoftware Only v2102025-08-08
00195278951717EchoPACGE Vingmed Ultrasound A/SPlug-In v2102025-08-08
00198953001387Venue SprintGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCR62025-07-31
00198953030233CaptionGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCAI2025-07-28
00195278884725VscanGE Vingmed Ultrasound A/SAir R3 for Android2025-05-22
00195278884749VscanGE Vingmed Ultrasound A/SAir R3 for iOS2025-05-22
09353278000823Kosmos OTS iOS ECHONOUS, INC.iOS 4.X2025-02-21
68051887046715THD Procto Software SystemTHD SPATHD DIGITAL MOBILE LIGHT2025-02-20
03760415600000B-Right Screen Fetal HeartBRIGHTHEARTV1.0.02025-01-28
03770024341041Sonio Detect SONIO22025-01-13
00860006305727See-Mode TechnologiesSEE-MODE TECHNOLOGIES PTE. LTD.See-Mode Augmented Reporting Tool, Thyroid (SMART-2024-11-22
03770033463000FETOLY-HEARTDIAGNOLY12024-10-25
00195278754011Venue SprintGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCR52024-07-10
B630QVCS346QVCAD SystemQVIEW MEDICAL3.4.62024-06-26
B630QVCSIK1202346QVCAD System Installation KitQVIEW MEDICAL12.02-3.4.62024-06-26
09353278000762Kosmos OTS iOS ECHONOUS, INC.P0079442024-05-06
00860003586341Caption AI (Caption Guidance + Caption Interpretation)CAPTION HEALTH, INC.Alastor2024-04-01
68051887043295THD Procto Software SystemTHD SPATHD DIGITAL MOBILE2023-12-14
68051887043301THD Procto Software SystemTHD SPATHD DIGITAL MOBILE MANOMETRY2023-12-14
68051887043318THD Procto Software SystemTHD SPATHD DIGITAL MOBILE ECOGRAPHY2023-12-14
68051887043325THD Procto Software SystemTHD SPATHD DIGITAL MOBILE ADVANCED2023-12-14
03770023859011HepatoscopeE-SCOPICSV22023-11-11
05060878810052ScanNav Anatomy Peripheral Nerve BlockINTELLIGENT ULTRASOUND LIMITEDV2.02023-11-06
00860003586334Caption GuidanceCAPTION HEALTH, INC.Apollo2023-09-30
00195278640550VscanGE Vingmed Ultrasound A/SAir R2 for iOS2023-09-26
00195278640567VscanGE Vingmed Ultrasound A/SAir R2 for Android2023-09-26
00195278640574VscanGE Vingmed Ultrasound A/SAir R2 CL2023-09-26
00860006305703See-Mode TechnologiesSEE-MODE TECHNOLOGIES PTE. LTD.AVA (Augmented Vascular Analysis)2023-08-16
09353278000717Kosmos OTS iOS Software PackageECHONOUS, INC.P0076392023-03-06
05060878810021ScanNav Anatomy Peripheral Nerve BlockINTELLIGENT ULTRASOUND LIMITEDV1.12023-03-01
09353278000700Kosmos OTS Android Doppler Software PackageECHONOUS, INC.P0077012023-02-03
18033737712341THD Procto Software SystemTHD SPATHD 4K CAM2022-10-07
58051887042642THD Procto Software SystemTHD SPATHD HRStation2022-10-07
B630QVCS344QVCAD SystemQVIEW MEDICAL3.4.42022-10-06
B630QVCSIK1010344QVCAD System Installation KitQVIEW MEDICAL10.10-3.4.42022-10-06
09353278000687Kosmos OTS Android LinearECHONOUS, INC.P0072132022-09-06
09353278000694Kosmos OTS Android Linear ColorECHONOUS, INC.P0074652022-09-06
07290019352006Lvivo Software Application PlatformDIA IMAGING ANALYSIS LTDLvivo_Platform2022-08-31
07290019352013Lvivo MobileDIA IMAGING ANALYSIS LTDLvivo_Mobile2022-08-31
07290019352020Lvivo SeamlessDIA IMAGING ANALYSIS LTDLvivo_Seamless2022-08-31
07290019352037Lvivo Standalone UIDIA IMAGING ANALYSIS LTDLvivo_UI2022-08-31
00884838107069UroNavPhilips DS North America LLCUroNav 42022-07-22
00860003586310Caption AI (Caption Guidance + Caption Interpretation)CAPTION HEALTH, INC.Adonis2022-03-15
00860003586303Caption AI (Caption Guidance + Caption Interpretation)CAPTION HEALTH, INC.0.10, 0.11, 1.1, 1.2, 1.3, 1.42020-06-05
B630QVCSIK1010343QVCAD System Installation KitQVIEW MEDICAL10.10-3.4.32021-12-09
B630QVCS343QVCAD SystemQVIEW MEDICAL3.4.32021-12-07
08033737713037THD Procto Software SystemTHD SPATHD Procto Software2021-07-19
18033737712389THD Procto Software SystemTHD SPATHD Proctostation2021-07-19
00850001977043VaveVave Health, Inc.VUA2021-06-14
B725INITVV1Visualize:VascularSALIENT IMAGING1.22021-06-04
B630QVCS342QVCAD SystemQVIEW MEDICAL3.4.22021-05-14
00840682147071VscanGE Vingmed Ultrasound A/SAir for iOS2021-02-23
00840682147101VscanGE Vingmed Ultrasound A/SAir for Android2021-02-23
05060634690010EchoGoULTROMICS LIMITEDPro2021-02-05
00840682146883EchoPACGE Vingmed Ultrasound A/SSoftware Only v2042020-09-23
00840682146876EchoPACGE Vingmed Ultrasound A/SPlug-in v2042020-09-22
04719875621130AmCAD UT DetectionAMCAD BIOMED CORPORATION2.22020-08-27
00884838089648InvivoPhilips DS North America LLC7840262019-08-24
00840682103961EchoPACGE Vingmed Ultrasound A/SSoftware Only v2012016-08-01
00840682104333EchoPACGE Vingmed Ultrasound A/SPlug-in v2012016-08-01
00840682121095EchoPACGE Vingmed Ultrasound A/SSoftware Only v1132016-09-19
00840682123501EchoPACGE Vingmed Ultrasound A/SSoftware Only v2022017-06-23
00840682123518EchoPACGE Vingmed Ultrasound A/SPlug-in v2022017-06-23