ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System

🇺🇸Siemens Medical Solutions USA, Inc. · 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 #K240704

Product codeIYN

Decision dateJul 22, 2024

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🇺🇸Siemens Medical Solutions USA, Inc.

Foundedunknown

Cite this page

RadPigeon. "ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE  Diagnostic Ultrasound System (Siemens Medical Solutions USA, Inc.)." AI Devices registry. https://radpigeon.news/ai/device/acuson-sequoia-diagnostic-ultrasound-system-acuson-sequoia-select-diagnostic-ult-3

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