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Sequoia Plus Diagnostic Ultrasound System

by Siemens Medical Solutions USA, Inc., Ultrasound DI

510(k) K072365

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 NumberK072365 Date17 Oct 2007ClearedStatusActive

Recalls

3 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0826-2011 FDA Unclassified (pre-2012) initiated 29 Sep 2010
    • Terminated Z-0827-2011 FDA Unclassified (pre-2012) initiated 29 Sep 2010

    There is the possibility of a short occurring in the transducer which could cause focal heating on the probe face.

    • Terminated Z-2149-2011 FDA Unclassified (pre-2012) initiated 10 Jul 2009 on shared 510(k) K072365

    Burn risk-- due to coolant leaks, patients may suffer burns or blisters due to increased temperature.

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  • Withdrawn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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