Syngo.via

• • Terminated Z-1778-2018 FDA Class II ·initiated 27 Mar 2018

  Functionality in the report sections "Findings Information" and "Summary of Measured Findings" not functioning properly. The corrected values modified in the report are neither saved, nor printed, nor sent to the information system. The system will still use original values.

• • Terminated Z-1261-2018 FDA Class II ·initiated 10 Jan 2018

  When the archiving configuration is changed, data received/created after the upgrade may be flagged as "Not to be archived". This is caused by the automatic function for cleaning up temporary data being disabled by the software upgrade. Due to the disabled cleanup function, disc capacity for free space decreases faster than usual. Unless the archiving configuration and the cleanup automatic function are reverted back to the original state (prior to the software upgrade), data that was incorrectly flagged "Not to be archived" must be manually prevented from being deleted by either clinical administrator or service engineer.

• • Terminated Z-1303-2018 FDA Class II ·initiated 8 Jan 2018

  A software functionality in the report sections Findings Information and Summary of Measured Findings is not performing properly. The system will use the original values instead of displaying and saving corrected/modified values. Outdated information could be sent to the referring physician when creating the formal report in the reporting system.

• • Terminated Z-0808-2018 FDA Class II ·initiated 31 Aug 2017

  A software update was released on August 22, 2017. Performing this software installation and upgrading syngo.via system to the software version VB20A_HF02 will resolve various bugs and inconsistent diagnosis with the old system.

• • Terminated Z-1689-2017 FDA Class II ·initiated 6 Mar 2017

  Software changes now available to address several issues

• • Terminated Z-2853-2016 FDA Class II ·initiated 5 Aug 2016

  Software error. Incorrect values for the volume calculation from a freehand VOI at the customer site. In volume calculations of prostate as well as in volume calculations of liver were too high.

• • Terminated Z-2245-2016 FDA Class II ·initiated 23 Jun 2016

  Incorrect values for the volume calculation. Software update VB30B via Update Instructions SY018/16/P to resolve software errors.

• • Terminated Z-1705-2015 FDA Class II ·initiated 15 May 2015

  measurements drawn on the 2nd and subsequent images of the series are not visible on printouts when the series is sent to print.

510(k) Number

K123375 ↗

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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