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. · K240704 · 2024-07-22

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), K240704) with a decision date of 2024-07-22. Review panel: Radiology.

FDA submission numberK240704
Pathway510(k)
CompanySiemens Medical Solutions, USA, Inc.
Review panel (specialty)Radiology
FDA decision date2024-07-22
DecisionSubstantially Equivalent
Product codeIYN
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Device class2
Regulation number892.1550
Review time (calendar days)130
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.