K260844

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

510(k) number
K260844
Device name
ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System
Applicant
Siemens Medical Solutions USA, Inc. WA · US
Product code
IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Decision date
2026-06-16
Date received
2026-03-16
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Radiology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain

Also available from FDA: K260844.pdf

Official FDA record: K260844
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.