Cleared Traditional

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

K242523 · Siemens Medical Solutions USA, Inc. · Radiology

Nov 2024

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K242523 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 November 19, 2024, 88 days after receiving the submission on August 23, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number	K242523 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 23, 2024
Decision Date	November 19, 2024
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF