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ACUSON SC2000 Diagnostic Ultrasound System

by Siemens Medi Cal Solutions, Inc. 4 variants

510(k) K130754

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 NumberK130754 Date25 Mar 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  • Withdrawn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, 22 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 SC2000 Diagnostic Ultrasound System is a medical imaging device that provides full volume imaging with a comprehensive suite of imaging options and AI-powered applications for structural heart disease assessment. It features an imaging engine utilizing up to 884,736 receive analytic processing channels for instantaneous full volume data acquisition, beam formation, image formation, and processing.

This system is supplied by Siemens Medical Solutions USA, Inc. and is authorized under FDA 510(k) clearance with product code IYN. It is designed for use in radiology settings and is intended to provide workflow efficiency and precision in diagnostic imaging procedures.

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Questions

AI-generated answers, 22 Sep 2026

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

  • What is the ACUSON SC2000 Diagnostic Ultrasound System used for?

    The ACUSON SC2000 is a medical imaging device designed for radiology settings, providing full volume imaging with comprehensive options and AI-powered applications specifically for structural heart disease assessment.

  • How is the ACUSON SC2000 Diagnostic Ultrasound System supplied?

    The system is supplied by Siemens Medical Solutions USA, Inc. and is authorized under FDA 510(k) clearance with product code IYN, designed to enhance workflow efficiency and precision in diagnostic imaging procedures.

  • What are the key technical specifications of the ACUSON SC2000?

    The ACUSON SC2000 features an imaging engine utilizing up to 884,736 receive analytic processing channels for instantaneous full volume data acquisition, beam formation, image formation, and processing capabilities.

  • What is the regulatory status of the ACUSON SC2000 Diagnostic Ultrasound System?

    The ACUSON SC2000 is authorized under FDA 510(k) clearance with product code IYN, received on March 19, 2013, and was determined to be substantially equivalent by the Radiology advisory committee.