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Syngo Dynamics, Version 6.0

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

Active United States

510(k) K070322

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK070322 Date27 Feb 2007ClearedStatusActive

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  • Withdrawn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-0545-2009 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-1751-2008 FDA Unclassified (pre-2012) initiated 8 Feb 2008

    Incorrect data: A software bug may result in a transfer of patient demographic data to a different patient's file.

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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