V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System

Samsung Medison Co., Ltd. · K231772 · 2023-10-03

V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System is an AI-enabled medical device from Samsung Medison Co., Ltd., listed by FDA (510(k), K231772) with a decision date of 2023-10-03. Review panel: Radiology.

FDA submission numberK231772
Pathway510(k)
CompanySamsung Medison Co., Ltd.
Review panel (specialty)Radiology
FDA decision date2023-10-03
DecisionSubstantially Equivalent
Product codeIYN
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Device class2
Regulation number892.1550
Review time (calendar days)109
Applicant countryKR

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.