HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System

Samsung Medison Co., Ltd. · K252018 · 2026-01-05

HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System is an AI-enabled medical device from Samsung Medison Co., Ltd., listed by FDA (510(k), K252018) with a decision date of 2026-01-05. Review panel: Radiology.

FDA submission numberK252018
Pathway510(k)
CompanySamsung Medison Co., Ltd.
Review panel (specialty)Radiology
FDA decision date2026-01-05
DecisionSubstantially Equivalent
Product codeIYN
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Device class2
Regulation number892.1550
Review time (calendar days)189
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.