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Siemens Acuson 2000 Ultrasound System with Abvs Transducer

by Siemens Medical Solutions USA, Inc., Ultrasound DI

510(k) K081148

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

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 NumberK081148 Date22 Dec 2008ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-1063-2015 FDA Class II initiated 12 Jan 2015

    There is a low probability the scanner arm will become completely detached from the scanner column.

    • Terminated Z-0930-2013 FDA Class II initiated 18 Jan 2013

    On some ACUSON S2000 ABVS systems, the inside of the transducer pod may contain sharp edges.

    • Terminated Z-2150-2011 FDA Unclassified (pre-2012) initiated 28 Mar 2011 on shared 510(k) K081148

    The weld connecting the ABVS arm to the system base has the potential to fail, causing the arm to fall off of the unit.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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

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