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Acuson Antares Diagnostic Ultrasound System

by Siemens Medical Solutions USA, Inc., Ultrasound DI

510(k) K063803

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

9 closed

Documents

Trust

Unverified

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

Overview

The ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEM is a highly advanced diagnostic ultrasound system designed for radiologists to enhance their diagnostic capabilities. With its exceptional image quality, ease of use, and reliability, this system has become a staple in many medical institutions around the world.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK063803 Date5 Jan 2007ClearedStatusActive

Recalls

9 recalls · FDA

    • Terminated Z-1836-2011 FDA Unclassified (pre-2012) initiated 17 Aug 2010

    There is an error in the estimation of mean pressure gradient in the Cardiac measurement package. The currently implemented calculation will result in an underestimation of the mean pressure gradient (PGmean) when estimated from a trace of the Doppler waveform of the stenotic flow.

    • Terminated Z-1853-2011 FDA Unclassified (pre-2012) initiated 1 Mar 2010

    Image captured from the device may be erroneous.

  • 3 recalls, same reason

    • Terminated Z-1005-2011 FDA Unclassified (pre-2012) initiated 2 Oct 2009
    • Terminated Z-1006-2011 FDA Unclassified (pre-2012) initiated 2 Oct 2009 on shared 510(k) K063803
    • Terminated Z-1007-2011 FDA Unclassified (pre-2012) initiated 2 Oct 2009 on shared 510(k) K063803

    ECG waveform does not accurately align with 2D, M-Mode or Spectral Images.

  • 2 recalls, same reason

    • Terminated Z-1766-2008 FDA Unclassified (pre-2012) initiated 21 Mar 2008
    • Terminated Z-1767-2008 FDA Unclassified (pre-2012) initiated 21 Mar 2008 on shared 510(k) K063803

    Software issue may result in distorted images and inaccurate measurements, which could lead to a misdiagnosis.

    • Terminated Z-0298-2008 FDA Unclassified (pre-2012) initiated 10 Jul 2007

    Image error: A software problem results in on-screen indications (graphics) that lead the user to believe that the patient's right and left and the transducer orientation are oriented the same. This is not the case and the actual patient's right and left are reversed from the on-screen indicators.

    • Terminated Z-0297-2008 FDA Unclassified (pre-2012) initiated 10 Jul 2007

    Image errors: A software problem results in on-screen indications (graphics) that lead the user to believe that the patient's right and left and the transducer orientation are oriented the same. This is not the case and the actual patient's right and left are reversed from the on-screen indicators.

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
IYN
Device Class
Class II
Regulation
21 CFR Part 892.1550
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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