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Syngo Imaging Version V20A

by Siemens AG Medical Solutions

510(k) K052461

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 NumberK052461 Date22 Sep 2005ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-1622-2014 FDA Class II initiated 3 Apr 2014

    A complaint reported that the archiving method at one customer site was changed from implicit to explicit, and the cleanup procedure enabled by the explicit archivingmethod may have deleted data from archive itself.

    • Terminated Z-0102-2009 FDA Unclassified (pre-2012) initiated 22 Aug 2008

    Image may not be visible after merge.

    • Terminated Z-0070-2007 FDA Unclassified (pre-2012) initiated 5 Sep 2006

    Potential issue with annotation function. Annotations, shown as overlays, may change font size when the image is saved. Text may appear shifted, or lines appear thicker, and their position may not be as intended.

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  • Withdrawn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
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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