Cleared Traditional

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

K251481 · Siemens Medical Solutions USA, Inc. · Radiology

Aug 2025

Decision

99d

Days

Class 2

Risk

About This 510(k) Submission

K251481 is an FDA 510(k) clearance for the ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by Siemens Medical Solutions USA, Inc. (Issaquah, US). The FDA issued a Cleared decision on August 20, 2025, 99 days after receiving the submission on May 13, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number	K251481 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 13, 2025
Decision Date	August 20, 2025
Days to Decision	99 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF