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Acuson S2000 and S3000

by Siemens Medical Solutions USA, Inc.

510(k) K130881

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK130881 Date11 Oct 2013ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
IYN
Device class
Class II
Regulation
21 CFR Part 892.1550
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Acuson S2000 and S3000 are diagnostic ultrasound systems designed for imaging internal body structures using high-frequency sound waves. These systems provide real-time visualization of organs, tissues, and blood flow, supporting applications in obstetrics, cardiology, abdominal, and vascular diagnostics. Their advanced imaging capabilities include elastography and contrast-enhanced ultrasound, enhancing diagnostic accuracy for various clinical assessments.

These systems are supplied as reusable medical devices intended for use in clinical, hospital, or diagnostic imaging settings. They are not sterile upon delivery and require proper cleaning, disinfection, and maintenance as per manufacturer guidelines. The Acuson S2000 and S3000 comply with FDA 510(k) clearance under the Radiology advisory committee, classified under product code IYN. No specific MRI safety classification or single-use designation is indicated in the provided data.

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