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Syngo Dynamics, Version 9.0

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

Active United States

510(k) K102150

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK102150 Date5 Oct 2010ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

7 recalls · FDA

    • Terminated Z-0826-2016 FDA Class II initiated 29 Jan 2016

    Siemens is releasing a software update that addresses an issue of mixing data from multiple patients. In rare situations, echo trend graphs may mix data from multiple patients.

    • Terminated Z-1183-2016 FDA Class II initiated 25 Jan 2016

    Siemens' conducting a recall due to a potential issue when using the measurement package of the VA10 version of syngo Dynamics.

    • Terminated Z-1613-2014 FDA Class II initiated 3 Apr 2014

    Systems with the affected serial number are experiencing a software error which may lead to incorrect patient demographics display.

    • Terminated Z-1216-2014 FDA Class II initiated 27 Jan 2014

    Potential patient data mixup. Improper error handling could allow for two different patients to be displayed in syngo Dynamics. Images shown for one patient and reporting system shown for a different patient, leading to the potential for misdiagnosis.

    • Terminated Z-1859-2013 FDA Class II initiated 10 Jun 2013

    Siemens initiate this recall due to a potential issue when using the sDIS matching rules of the syngo Dynamics Information System version 9.5 or VA10A with modality device configured to end study at association close. Images or DICOM SR objects sent from a modality device to syngo Dynamics may not be saved when the modality is configured at syngo Dynamics to end study at association close, and whe

    • Terminated Z-2219-2012 FDA Class II initiated 13 Jul 2012

    If multiple uncompressed images/clips are sent to the syngo Dynamics server, around the same time, it is possible for an image from a patient to be placed in another patient's study.

    • Terminated Z-2293-2011 FDA Unclassified (pre-2012) initiated 24 Mar 2011

    If one or more graphs are in a table on the report, and if any of those graphs are deleted, it may lead to reports failing to save and/or marking the study as read might leave the study in an unread state or might mark the study as read but leave the report with a "Preliminary" watermark displayed.

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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