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. · System, Imaging, Pulsed Doppler, Ultrasonic

What it does

Supports the imaging workflow around multi-modality studies — routing, scheduling, or image management — rather than interpreting the images.

Who it's for

Imaging departments and informatics teams managing study flow.

Reported performance

No sensitivity / specificity / AUC was disclosed in the available summary. Many summaries report no standalone metrics — we note that honestly rather than imply a number.

Performance numbers are manufacturer-reported and often single-site; treat them as a starting point, not an independent benchmark.

FDA

Pathway510(k)

Submission #K252018

Product codeIYN

Decision dateJan 5, 2026

PanelRadiology

FDA recordaccessdata

EU (CE)

Statusunknown

Risk class—

Notified body—

EMDN code—

Basic UDI-DI—

AI Act class—

EU coverage is filling out through 2026; absence here doesn't mean a device isn't CE-marked.

Vendor

Company🇰🇷Samsung Medison Co., Ltd.

Foundedunknown

Cite this page

RadPigeon. "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.)." AI Devices registry. https://radpigeon.news/ai/device/hera-z20-diagnostic-ultrasound-system-hera-z20e-diagnostic-ultrasound-system-her

Last updated Jun 29, 2026. Information only — not clinical advice. Summaries are RadPigeon's own wording.