Voluson Expert 18; Voluson Expert 20; Voluson Expert 22

Ge Medical Systems Ultrasound and Primary Care Diagnostics · K252328 · 2025-11-24

Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 is an AI-enabled medical device from Ge Medical Systems Ultrasound and Primary Care Diagnostics, listed by FDA (510(k), K252328) with a decision date of 2025-11-24. Review panel: Radiology.

FDA submission numberK252328
Pathway510(k)
CompanyGe Medical Systems Ultrasound and Primary Care Diagnostics
Review panel (specialty)Radiology
FDA decision date2025-11-24
DecisionSubstantially Equivalent
Product codeIYN
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Device class2
Regulation number892.1550
Review time (calendar days)122
Applicant countryUS

Official FDA database record · FDA AI-enabled device list

More devices from Ge Medical Systems Ultrasound and Primary Care Diagnostics · All Radiology AI devices · Full device index

Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.