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ACUSON SC2000 Diagnostic Ultrasound System

by Siemens Medical Solutions USA, Inc. 4 variants

510(k) K233613

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 · Special NumberK233613 Date12 Jun 2024ClearedStatusActive

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  • Withdrawn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
IYO
Device Class
Class II
Regulation
21 CFR Part 892.1560
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 designed to provide diagnostic ultrasound capabilities. It features a suite of imaging options and applications intended to support clinical assessment and structural heart disease evaluation.

This system is supplied for use by technologists and physicians in clinical settings. It has received FDA 510(k) clearance under the identifier K233613. Users should refer to the system controls and training modules for proper operation and image management.

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