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Syngo Dynamics, Version 5.0

by Siemens Medical Solutions USA, Inc. 510(k)

Active United States

510(k) K053133

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK053133 Date5 Dec 2005ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

2 recalls · FDA

    • Terminated Z-0544-2009 FDA Unclassified (pre-2012) initiated 23 Jul 2008

    If the text is manually modified and additional phrases added as a result of worksheet interactions, some of the phrases may not populate the report.

    • Terminated Z-0652-2007 FDA Unclassified (pre-2012) initiated 31 Jan 2007

    The cardiac calculation feature may incorrectly calculate a derived V max value (reported out lower than it should be) and certain values imported into worksheets and reports may be incorrect due to a software defect.

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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