V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System

Samsung Medison Co., Ltd. · K250999 · 2025-07-18

V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System is an AI-enabled medical device from Samsung Medison Co., Ltd., listed by FDA (510(k), K250999) with a decision date of 2025-07-18. Review panel: Radiology.

FDA submission numberK250999
Pathway510(k)
CompanySamsung Medison Co., Ltd.
Review panel (specialty)Radiology
FDA decision date2025-07-18
DecisionSubstantially Equivalent
Product codeIYN
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Device class2
Regulation number892.1550
Review time (calendar days)108
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.