V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System

Samsung Medison Co., Ltd. · K242511 · 2024-12-10

V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System is an AI-enabled medical device from Samsung Medison Co., Ltd., listed by FDA (510(k), K242511) with a decision date of 2024-12-10. Review panel: Radiology.

FDA submission numberK242511
Pathway510(k)
CompanySamsung Medison Co., Ltd.
Review panel (specialty)Radiology
FDA decision date2024-12-10
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

More devices from Samsung Medison Co., Ltd. · All Radiology AI devices · Full device index

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