Radiology AI Directory

Vendor

GE Medical Systems Ultrasound and Primary Care Diagnostics

31 FDA-cleared listings in this directory.

Claim vendor profile
FDA-cleared K260673

LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power

GE Medical Systems Ultrasound and Primary Care Diagnostics

LOGIQ Vita and S20 are general-purpose diagnostic ultrasound systems for fetal and obstetric, abdominal, pediatric, small-organ, cephalic, cardiac, peripheral-vascular,...

Modality
Ultrasound
Anatomy
Fetus; abdomen; pelvis; small organs; head; heart; peripheral vessels; musculoskeletal; and urologic organs
Decision
2026-03-24
Cardiac imagingUltrasound workflow
FDA-cleared K253370

LOGIQ Totus

GE Medical Systems Ultrasound and Primary Care Diagnostics

LOGIQ Totus is a general-purpose diagnostic ultrasound system for the labeled fetal, obstetric, abdominal, pediatric, small-organ, cephalic, cardiac, vascular, musculoskeletal,...

Modality
Ultrasound
Anatomy
Fetus; abdomen; pelvis; small organs; head; heart; peripheral vessels; musculoskeletal; and urologic organs
Decision
2026-01-08
Cardiac imagingUltrasound workflow
FDA-cleared K253366

LOGIQ Fortis

GE Medical Systems Ultrasound and Primary Care Diagnostics

LOGIQ Fortis is a general-purpose diagnostic ultrasound system for the labeled fetal, obstetric, abdominal, pediatric, small-organ, cephalic, cardiac, vascular, musculoskeletal,...

Modality
Ultrasound
Anatomy
Fetus; abdomen; pelvis; small organs; head; heart; peripheral vessels; musculoskeletal; and urologic organs
Decision
2026-01-07
Cardiac imagingUltrasound workflow
FDA-cleared K252328

Voluson Expert 18; Voluson Expert 20; Voluson Expert 22

Ge Medical Systems Ultrasound and Primary Care Diagnostics

Voluson Expert 18, 20, and 22 are general-purpose diagnostic ultrasound systems for qualified healthcare professionals across the labeled fetal, obstetric, gynecologic, abdominal,...

Modality
Ultrasound
Anatomy
Fetal, gynecologic, abdominal, cardiac, vascular, and small-organ anatomy
Decision
2025-11-24
Cardiac imagingUltrasound workflow
FDA-cleared K251963

LOGIQ E10s

Ge Medical Systems Ultrasound and Primary Care Diagnostics

LOGIQ E10s is a general-purpose diagnostic ultrasound system supporting the labeled adult, pediatric, cardiac, vascular, abdominal, obstetric, small-organ, musculoskeletal,...

Modality
Ultrasound
Anatomy
Multi-region
Decision
2025-10-29
Cardiac imagingUltrasound workflow
FDA-cleared K251985

LOGIQ E10

Ge Medical Systems Ultrasound and Primary Care Diagnostics

LOGIQ E10 is a general diagnostic ultrasound system for qualified users across fetal and obstetric, abdominal, gynecologic, pediatric, small-organ, breast, cardiac, vascular,...

Modality
Ultrasound
Anatomy
Multi-region
Decision
2025-10-29
Breast imagingCardiac imagingUltrasound workflow
FDA-cleared K251342

EchoPAC Software Only / EchoPAC Plug-in

GE Medical Systems Ultrasound and Primary Care Diagnostics

EchoPAC Software Only and Plug-in provide diagnostic review, analysis, recording, and reporting functions for ultrasound images, including raw GE and DICOM ultrasound data.

Modality
Ultrasound
Anatomy
Whole body and anatomy represented in the labeled ultrasound applications
Decision
2025-07-16
Ultrasound workflow
FDA-cleared K251169

Vivid Pioneer

GE Medical Systems Ultrasound and Primary Care Diagnostics

Vivid Pioneer is a general-purpose ultrasound system with the labeled adult and pediatric cardiac, vascular, abdominal, obstetric, small-organ, musculoskeletal, urologic,...

Modality
Ultrasound
Anatomy
Multi-region
Decision
2025-07-10
Cardiac imagingUltrasound workflow
FDA-cleared K250543

Voluson™ Performance 16; Voluson™ Performance 18

GE Medical Systems Ultrasound and Primary care Diagnostics

Voluson Performance 16 and 18 are general-purpose diagnostic ultrasound systems for imaging, measurement, display, and analysis of the human body and fluid across the labeled...

Modality
Ultrasound
Anatomy
Fetal, obstetric, abdominal, pelvic, pediatric, small-organ, cephalic, cardiac, vascular, musculoskeletal, lung, and urologic anatomy
Decision
2025-05-29
Cardiac imagingQuantification and segmentationUltrasound workflow
FDA-cleared K250087

Vscan Air

GE Medical Systems Ultrasound and Primary Care Diagnostics

Vscan Air is a wireless handheld point-of-care ultrasound system for broad adult, pediatric, and neonatal applications. K250087 adds deep-learning automatic bladder-volume...

Modality
Ultrasound
Anatomy
Multi-region
Decision
2025-05-01
Quantification and segmentationUltrasound workflow
FDA-cleared K243620

Vivid iq

GE Medical Systems Ultrasound and Primary Care Diagnostics

Vivid iq is a compact Track 3 general-purpose diagnostic ultrasound system for trained healthcare professionals, with labeled cardiac, vascular, abdominal, obstetric, small-organ,...

Modality
Ultrasound
Anatomy
Multi-region; cardiovascular and shared-service ultrasound applications
Decision
2025-02-11
Cardiac imagingUltrasound workflow
FDA-cleared K243628

Vivid T9/Vivid T8

GE Medical Systems Ultrasound and Primary Care Diagnostics

Vivid T9 and Vivid T8 are cardiac-focused general ultrasound systems; this release adds vascular-access support, Clarity+, DICOM PDF, nondiagnostic remote viewing, and workflow...

Modality
Ultrasound
Anatomy
Heart/Cardiovascular
Decision
2025-02-11
Cardiac imagingUltrasound workflow
FDA-cleared K242168

Voluson Expert 18; Voluson Expert 20; Voluson Expert 22

GE Medical Systems Ultrasound and Primary care Diagnostics

The Voluson Expert 18, 20, and 22 are general-purpose ultrasound systems for qualified and trained healthcare professionals. The FDA material describes fetal and obstetric,...

Modality
Ultrasound
Anatomy
Fetal/obstetric, abdominal, pelvic, cardiac, vascular, cephalic, small-organ, musculoskeletal, and urologic anatomy
Decision
2024-12-20
Cardiac imagingUltrasound workflow
FDA-cleared K233692

Voluson Signature 20, Voluson Signature 18

GE Medical Systems Ultrasound and Primary care Diagnostics

The Voluson Signature 18 and 20 are general-purpose diagnostic ultrasound systems with specialized OB/GYN use. The FDA material describes fetal and obstetric, abdominal,...

Modality
Ultrasound
Anatomy
Fetal/obstetric, abdominal, pelvic, cardiac, vascular, cephalic, small-organ, musculoskeletal, and urologic anatomy
Decision
2024-03-07
Cardiac imagingUltrasound workflow
FDA-cleared K232381

LOGIQ Totus

GE Medical Systems Ultrasound and Primary care Diagnostics

LOGIQ Totus is a general-purpose diagnostic ultrasound system for trained healthcare professionals to image, measure, display, and analyze the human body and fluid across the...

Modality
Ultrasound
Anatomy
Fetal/obstetric, abdominal, renal, gynecologic/pelvic, pediatric, breast, testes, thyroid, neonatal and adult cephalic, cardiac, vascular, musculoskeletal, urologic, transrectal, and transvaginal anatomy
Decision
2023-12-07
Breast imagingCardiac imagingQuantification and segmentation
FDA-cleared K231966

LOGIQ E10

GE Medical Systems Ultrasound and Primary care Diagnostics

LOGIQ E10 is a general-purpose diagnostic ultrasound system for broad adult and pediatric applications; K231966 adds AI-assisted renal measurements, anatomy-based preset and color...

Modality
Ultrasound
Anatomy
Multi-region
Decision
2023-11-07
Cardiac imagingQuantification and segmentationUltrasound workflow
FDA-cleared K231965

Voluson Expert 22, Voluson Expert 20, Voluson Expert 18

GE Medical Systems Ultrasound and Primary Care Diagnostics

Voluson Expert 22, Expert 20, and Expert 18 are general-purpose diagnostic ultrasound systems for qualified and trained healthcare professionals across the labeled...

Modality
Ultrasound
Anatomy
Fetal/obstetric, abdominal, gynecologic/pelvic, infertility-monitoring, pediatric, small-organ, cephalic, cardiac, musculoskeletal, vascular, transvaginal, and transrectal anatomy
Decision
2023-10-30
Cardiac imagingUltrasound workflow
FDA-cleared K220940

EchoPAC Software Only, EchoPAC Plug-in

GE Medical Systems Ultrasound and Primary Care Diagnostics

EchoPAC Software Only and EchoPAC Plug-in review and analyze supported GE ultrasound raw data and DICOM ultrasound images, manage patient records, and support reporting for the...

Modality
Ultrasound
Anatomy
Fetus; abdomen; pelvis; small organs; head; heart; peripheral vessels; musculoskeletal; thoracic; and urologic anatomy
Decision
2022-07-22
Cardiac imagingUltrasound workflow
FDA-cleared K221147

Vivid T8, Vivid T9

GE Medical Systems Ultrasound and Primary Care Diagnostics

Vivid T8 and Vivid T9 are general-purpose diagnostic ultrasound systems with specialized cardiac applications for fetal, abdominal, pediatric, small-organ, cephalic, cardiac,...

Modality
Ultrasound
Anatomy
Fetus; abdomen; pelvis; small organs; head; heart; peripheral vessels; musculoskeletal; thoracic; and urologic anatomy
Decision
2022-07-18
Cardiac imagingUltrasound workflow
FDA-cleared K220619

Vivid S60N, Vivid S70N

GE Medical Systems Ultrasound and Primary Care Diagnostics

Vivid S60N and Vivid S70N are general-purpose cardiac diagnostic ultrasound systems supporting adult and pediatric echocardiography and labeled thoracic or pleural ultrasound...

Modality
Ultrasound
Anatomy
Heart/Cardiovascular
Decision
2022-07-15
Cardiac imagingUltrasound workflow
FDA-cleared K220800

Venue Go

GE Medical Systems Ultrasound and Primary Care Diagnostics

Venue Go is a point-of-care diagnostic ultrasound system for trained users across broad adult, pediatric, and neonatal applications in hospital and clinical environments.

Modality
Ultrasound
Anatomy
Multi-region
Decision
2022-06-21
Ultrasound workflow
FDA-cleared K220358

Voluson Expert 22, Voluson Expert 20, Voluson Expert 18

GE Medical Systems Ultrasound and Primary Care Diagnostics

Voluson Expert 18, Voluson Expert 20, and Voluson Expert 22 are general-purpose diagnostic ultrasound systems for qualified healthcare professionals across the labeled fetal,...

Modality
Ultrasound
Anatomy
Fetus; abdomen; pelvis; small organs; head; heart; peripheral vessels; musculoskeletal; thoracic; and urologic anatomy
Decision
2022-06-06
Cardiac imagingUltrasound workflow
FDA-cleared K220446

Versana Balance

GE Medical Systems Ultrasound and Primary Care Diagnostics

Versana Balance is a general-purpose diagnostic ultrasound system for imaging, measurement, display, and analysis of the human body and body fluids across the labeled fetal,...

Modality
Ultrasound
Anatomy
Fetus; abdomen; pelvis; small organs; head; heart; peripheral vessels; musculoskeletal; thoracic; and urologic anatomy
Decision
2022-05-11
Cardiac imagingQuantification and segmentationUltrasound workflow
FDA-cleared K210438

Versana Premier

GE Medical Systems Ultrasound and Primary Care Diagnostics

Versana Premier is a general diagnostic ultrasound system for fetal and obstetric, abdominal, gynecologic, urologic, pediatric, small-organ, cardiac, vascular, musculoskeletal,...

Modality
Ultrasound
Anatomy
Multi-region
Decision
2021-09-10
Cardiac imagingUltrasound workflow
FDA-cleared K200852

EchoPAC Software Only, EchoPAC Plug-In

GE Medical Systems Ultrasound and Primary Care Diagnostics

EchoPAC Software Only and EchoPAC Plug-in are intended for diagnostic review and analysis of ultrasound images, patient-record management, and reporting for use by or on the order...

Modality
Ultrasound
Anatomy
Fetal, abdominal, pelvic, urologic, pediatric, small-organ, cephalic, cardiac, vascular, transesophageal, musculoskeletal, transrectal, transvaginal, intraoperative, intracardiac, and intraluminal anatomy
Decision
2020-09-18
Cardiac imagingUltrasound workflow
FDA-cleared K200851

Vivid T8, Vivid T9

GE Medical Systems Ultrasound and Primary Care Diagnostics

Vivid T8 and Vivid T9 are general-purpose ultrasound systems specialized for cardiac imaging and intended for qualified and trained healthcare professionals for ultrasound...

Modality
Ultrasound
Anatomy
Fetal, abdominal, pelvic, urologic, pediatric, small-organ, cephalic, cardiac, vascular, musculoskeletal, transcranial, transesophageal, transrectal, transvaginal, interventional, and intraoperative anatomy
Decision
2020-09-09
Cardiac imagingQuantification and segmentationUltrasound workflow
FDA-cleared K200497

Vivid S60N, Vivid S70N

GE Medical Systems Ultrasound and Primary Care Diagnostics

Vivid S60N and Vivid S70N are general-purpose cardiac diagnostic ultrasound systems supporting adult and pediatric echocardiography and the labeled thoracic or pleural ultrasound...

Modality
Ultrasound
Anatomy
Heart/Cardiovascular
Decision
2020-07-16
Cardiac imagingUltrasound workflow
FDA-cleared K181685

Vivid E80, Vivid E90, Vivid E95

GE Medical Systems Ultrasound and Primary Care Diagnostics

Vivid E80, Vivid E90, and Vivid E95 are general-purpose ultrasound systems specialized for cardiac imaging and intended for use by or under the direction of a qualified physician...

Modality
Ultrasound
Anatomy
Fetal, abdominal, pelvic, pediatric, small-organ, cephalic, cardiac, vascular, musculoskeletal, urologic, transesophageal, transrectal, transvaginal, and intraoperative anatomy
Decision
2018-10-25
Cardiac imagingUltrasound workflow
FDA-cleared K180599

Venue

GE Medical Systems Ultrasound and Primary Care Diagnostics

Venue is a mobile point-of-care diagnostic ultrasound system for broad adult and pediatric applications in emergency, critical-care, office, clinic, and hospital settings; K180599...

Modality
Ultrasound
Anatomy
Multi-region
Decision
2018-05-02
Ultrasound workflow