FDA.reportPublic FDA data

General-purpose ultrasound imaging system

Definition
A stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.
GUDID devices
2,885
Last updated
2026-10-15 14:55:39

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00840682102933LOGIQGE Medical Systems (China) Co.,Ltd.V22016-08-01
00840682102940LOGIQGE Medical Systems (China) Co.,Ltd.V12016-08-01
00198953001400VenueGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCR6 UPG2025-11-17
00198953042731LOGIQGE Ultrasound Korea Ltd.E10s R3R4_R5 UPG HW2025-12-05
00198953042748LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCE10 R4_R5 UPG2025-12-05
00198953042755LOGIQGE Ultrasound Korea Ltd.E10s R3R4_R5 UPG2025-12-05
00198953042762LOGIQGE Ultrasound Korea Ltd.E10s R3R4_R5 SW UPG Wireless2025-12-05
00198953042779LOGIQGE Ultrasound Korea Ltd.E10s R3R4_R5 UPG HW Wireless2025-12-05
00198953042793LOGIQGE Ultrasound Korea Ltd.E10s R52025-12-05
00198953042816LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCE10 R52025-12-05
00198953078747LOGIQGE Medical Systems (China) Co.,Ltd.e X TP2026-06-10
00198953113493LOGIQGE Ultrasound Korea Ltd.Totus R5 SW upgrade2026-01-21
00198953121382VolusonGE Ultrasound Korea Ltd.Signature 20 BT272026-05-28
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLC7952082026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLC7952102026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLC7952182026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLC7952342026-09-18
00195278756138InveniaGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCABUS R2.5 Prime2025-03-12
00195278770271VolusonGE Healthcare Austria GmbH & Co OGExpert 22 BT252025-01-07
00195278814685VolusonGE Healthcare Austria GmbH & Co OGExp BT24 to BT25 UPG2025-01-08
00195278910509VolusonGE Ultrasound Korea Ltd.Performance 182025-06-04
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.V6 ONE2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.V7 ONE2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.V8 ONE2026-08-18
00195278674197LOGIQGE Medical Systems (China) Co.,Ltd.e TP2023-12-20
04953170264986SPARE FUSEOLYMPUS MEDICAL SYSTEMS CORP.MAJ-17092017-10-12
00195278347473VolusonGE Healthcare Austria GmbH & Co OGExpert 182022-08-16
00195278347480VolusonGE Healthcare Austria GmbH & Co OGExpert 202022-08-16
00195278347497VolusonGE Healthcare Austria GmbH & Co OGExpert 222022-06-14
00195278384041LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCE10 R32021-11-15
00195278439352LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCE10 R1 to R3 UPG2025-12-05
00195278439369LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCE10 R2 to R3 UPG2025-12-05
00195278464613LOGIQGE Ultrasound Korea Ltd.P8 R4.52022-03-28
00195278464620LOGIQGE Ultrasound Korea Ltd.P10 R4 to R4.5 SW Conversion2022-03-28
00195278464637LOGIQGE Ultrasound Korea Ltd.P9 R4.52022-03-28
00195278464644LOGIQGE Ultrasound Korea Ltd.P10 R4.52022-03-28
00195278464651LOGIQGE Ultrasound Korea Ltd.P9 R4 to R4.5 SW Conversion2022-03-28
00195278464668LOGIQGE Ultrasound Korea Ltd.P10 R4.5 HD2022-03-28
00195278464675LOGIQGE Ultrasound Korea Ltd.P9 R4 to R4.5 SW Conversion2022-03-28
00195278473011VolusonGE Ultrasound Korea Ltd.Performance to BT22 UPG2021-12-14
00195278473028VolusonGE Ultrasound Korea Ltd.Signature to BT22 UPG2021-12-14
00195278473042VolusonGE Ultrasound Korea Ltd.S10 Expert BT222021-12-14
00195278473059VolusonGE Ultrasound Korea Ltd.S10 T222021-12-14
00195278473066VolusonGE Ultrasound Korea Ltd.S8t BT222021-12-14
00195278473073VolusonGE Ultrasound Korea Ltd.S8 BT222021-12-14
00195278473080VolusonGE Ultrasound Korea Ltd.S6 BT222021-12-14
00195278473097VolusonGE Ultrasound Korea Ltd.P6 BT222021-12-14
00195278473103VolusonGE Ultrasound Korea Ltd.P8 BT222021-12-14
00195278487414LOGIQGE Ultrasound Korea Ltd.E10s R2 to R3 UPG2022-01-20
00195278111241LOGIQGE Ultrasound Korea Ltd.P8 R42021-02-17
00195278111258LOGIQGE Ultrasound Korea Ltd.P9 R42021-02-17
00195278111265LOGIQGE Ultrasound Korea Ltd.P10 R42021-02-17
00195278111272LOGIQGE Ultrasound Korea Ltd.P9 R3 to R4 UPG2021-02-17
00195278016812VolusonGE Healthcare Austria GmbH & Co OGE10 BT212020-09-21
00195278016829VolusonGE Healthcare Austria GmbH & Co OGE8 BT212020-09-21
00195278016836VolusonGE Healthcare Austria GmbH & Co OGE6 BT212020-09-21
00195278029010LOGIQGE Ultrasound Korea Ltd.S8 R3 OLED2020-06-25
00195278077592VolusonGE Healthcare Austria GmbH & Co OGE BT20 to BT21 UPG2020-09-21
00195278005830VenueGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCR3 UPG2020-11-24
00195278005861Venue GOGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCR3 UPG2020-11-24
00195278006820VOLUSONGE Ultrasound Korea Ltd.SWIFT+2020-10-28
00195278006837VolusonGE Ultrasound Korea Ltd.SWIFT2020-10-28
00841517139018iLOOKFUJIFILM SONOSITE, INC.P35000-102026-07-16
00840682110938LOGIQGE Ultrasound Korea Ltd.P92016-08-01
00840682118477VolusonGE Ultrasound Korea Ltd.S6 BT14 to BT15 UPG2016-08-01
00840682118484VolusonGE Ultrasound Korea Ltd.P8 BT14 to BT15 UPG2016-08-01
00840682118507VolusonGE Ultrasound Korea Ltd.P8 BT13 to BT14 UPG2016-08-01
00840682118514VolusonGE Ultrasound Korea Ltd.S8 BT12 to BT14 UPG2016-08-01
00840682118538VolusonGE Ultrasound Korea Ltd.S8 BT14 to BT15 UPG2016-08-01
00840682118545VolusonGE Ultrasound Korea Ltd.S6 BT12 to BT14 UPG2016-08-01
00840682121996VOLUSONGE Ultrasound Korea Ltd.S6 BT11 to BT12 UPG2016-10-14
00840682122009VOLUSONGE Ultrasound Korea Ltd.S8 BT11 to BT12 UPG2016-10-14
00866646000206Butterfly Network, Inc.Butterfly Network, Inc.Butterfly iQ2018-08-10
06938396440008SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.CTS-40002026-07-10
00852619008041QT Scanner 2000Qt Imaging, Inc.Model B2026-06-24
04056869173566ACUSON Sequoia Diagnostic Ultrasound SystemSIEMENS MEDICAL SOLUTIONS USA, INC.111487752018-05-07
04056869981062ACUSON Sequoia Select Diagnostic Ultrasound SystemSIEMENS MEDICAL SOLUTIONS USA, INC.116586352023-04-21
04056869996295ACUSON Origin Diagnostic Ultrasound SystemSIEMENS MEDICAL SOLUTIONS USA, INC.116685902023-12-19
04068151012477ACUSON Origin ICE Diagnostic Ultrasound SystemSIEMENS MEDICAL SOLUTIONS USA, INC.116694002024-08-22
00198953078716LOGIQGE Medical Systems (China) Co.,Ltd.e S2026-06-10