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 · K260673 · 2026-03-24

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 is an AI-enabled medical device from GE Medical Systems Ultrasound and Primary Care Diagnostics, listed by FDA (510(k), K260673) with a decision date of 2026-03-24. Review panel: Radiology.

FDA submission numberK260673
Pathway510(k)
CompanyGE Medical Systems Ultrasound and Primary Care Diagnostics
Review panel (specialty)Radiology
FDA decision date2026-03-24
DecisionSubstantially Equivalent
Product codeIYN
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Device class2
Regulation number892.1550
Review time (calendar days)22
Applicant countryUS

Official FDA database record · FDA AI-enabled device list

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