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Acuson

by Siemens Medical Solutions USA, Inc. 4 variants

510(k) K111674

Acuson is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K111674 on 30 Jun 2011, active as of 22 Oct 2026. One FDA recall is linked to it.

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK111674 Date30 Jun 2011ClearedStatusActive

Official records

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-1616-2012 FDA Not yet classified initiated 25 Apr 2012
    • Terminated Z-1684-2012 FDA Not yet classified initiated 23 Apr 2012 on shared 510(k) K111674
    • Terminated Z-1685-2012 FDA Not yet classified initiated 23 Apr 2012 on shared 510(k) K111674

    When using the Advanced SieClear spatial compounding feature a synchronization error may occur which can cause a mismatch between the image and the depth scale.

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

Timeline

4 dated events

  1. Cleared FDA 510(k) K111674
  2. Recall initiated FDA recalls Z-1684-2012
  3. Recall initiated FDA recalls Z-1685-2012
  4. Recall initiated FDA recalls Z-1616-2012

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  • Withdrawn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

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Similar devices

Other devices filed under FDA product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

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