K251481

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
K251481
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
2025-08-20
Date received
2025-05-13
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: K251481.pdf

Official FDA record: K251481
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.