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Somatom Sensation 64 and Sensation Cardiac

by Siemens Medical Solutions USA, Inc.

510(k) K040665

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 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 · Special NumberK040665 Date2 Apr 2004ClearedStatusActive

Recalls

5 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1306-2016 FDA Class II initiated 15 Feb 2016
    • Terminated Z-1305-2016 FDA Class II initiated 15 Feb 2016

    Siemens is initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM Sensation systems in conjunction with the use of the cardio licenses "Cardio Pro" and "Cardio Retro".

  • 2 recalls, same reason

    • Terminated Z-0321-2009 FDA Unclassified (pre-2012) initiated 3 Sep 2008
    • Terminated Z-0320-2009 FDA Unclassified (pre-2012) initiated 3 Sep 2008

    software error - does not allow protocol to properly synchronize with ECG triggers

    • Terminated Z-0795-06 FDA Unclassified (pre-2012) initiated 9 Mar 2006

    When using the LungCare feature in the SOMATOM CT Systems some marks made on CT images may not be saved.

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  • Withdrawn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
JAK
Device Class
Class II
Regulation
21 CFR Part 892.1750
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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