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. · K260844 · 2026-06-16

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), K260844) with a decision date of 2026-06-16. Review panel: Radiology.

FDA submission numberK260844
Pathway510(k)
CompanySiemens Medical Solutions USA, Inc.
Review panel (specialty)Radiology
FDA decision date2026-06-16
DecisionSubstantially Equivalent
Product codeIYN
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Device class2
Regulation number892.1550
Review time (calendar days)92
Applicant countryUS

Official FDA database record · FDA AI-enabled device list

More devices from Siemens Medical Solutions USA, Inc. · All Radiology AI devices · Full device index

Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.