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. · K251481 · 2025-08-20

ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System is an AI-enabled medical device from Siemens Medical Solutions USA, Inc., listed by FDA (510(k), K251481) with a decision date of 2025-08-20. Review panel: Radiology.

FDA submission numberK251481
Pathway510(k)
CompanySiemens Medical Solutions USA, Inc.
Review panel (specialty)Radiology
FDA decision date2025-08-20
DecisionSubstantially Equivalent
Product codeIYN
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Device class2
Regulation number892.1550
Review time (calendar days)99
Applicant countryUS

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.