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FDA-cleared K220882

Vivid E80, Vivid E90, Vivid E95

GE Medical Systems Ultrasound and

Authorized purpose: Vivid E80, Vivid E90, and Vivid E95 are general-purpose diagnostic ultrasound systems with specialized cardiac applications for imaging, measurement, display, and analysis across the labeled adult, pediatric, fetal, vascular, procedural, and other ultrasound applications.

Modality
Ultrasound
Anatomy
Fetus; abdomen; pelvis; small organs; head; heart; peripheral vessels; musculoskeletal; thoracic; and urologic anatomy
Decision
2022-07-22
FDA-cleared K200708

Vivid iq

GE Medical Systems Ultrasound and

Authorized purpose: Vivid iq is compact cardiovascular and shared-service ultrasound for cardiac, vascular, abdominal, obstetric, pediatric, and procedure-guidance applications.

Modality
Ultrasound
Anatomy
Heart/Cardiovascular
Decision
2020-09-09
FDA-cleared K200743

Vivid E80/ Vivid E90/ Vivid E95

GE Medical Systems Ultrasound and

Authorized purpose: Vivid E80, E90, and E95 are cardiovascular and general diagnostic ultrasound systems; K200743 adds AI-assisted cardiac measurements and Doppler-spectrum recognition, expanded ventricular and atrial function analysis, and qualified application-launch and DICOM-report functions.

Modality
Ultrasound
Anatomy
Heart/Cardiovascular
Decision
2020-07-23