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ACUSON SC2000 Diagnostic Ultrasound System

by Siemens Medical Solutions USA, Inc. 4 variants

510(k) K181098

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 NumberK181098 Date31 May 2018ClearedStatusActive

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  • Withdrawn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, 23 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 diagnostic ultrasound system. It is designed to provide diagnostic imaging capabilities. The system is used for diagnostic purposes. It is classified under the product code IYN.

The Acuson Sc2000 Diagnostic Ultrasound System is supplied by Siemens Medical Solutions USA, Inc. It has been authorized with FDA 510K clearance, with the decision description being Substantially Equivalent. The system has the k number K181098 and is reviewed by the Radiology advisory committee.

Other devices from Siemens Medical Solutions USA, Inc.

See all devices from Siemens Medical Solutions USA, Inc. →

Questions

AI-generated answers, 23 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 used for?

    The Acuson SC2000 is used for diagnostic purposes, providing diagnostic imaging capabilities.

  • What is the regulatory status of the Acuson SC2000?

    The system has been authorized with FDA 510K clearance, with a decision description of Substantially Equivalent, and has the k number K181098.

  • Who manufactures the Acuson SC2000?

    The Acuson SC2000 is supplied by Siemens Medical Solutions USA, Inc.

  • What product code is the Acuson SC2000 classified under?

    The system is classified under the product code IYN.