Syngo Imaging (Version V31)

• • Terminated Z-0405-2018 FDA Class II ·initiated 25 Jul 2017

  Siemens is releasing a letter to inform about potential data loss relevant to diagnosis.

• • Terminated Z-1349-2016 FDA Class II ·initiated 18 Jan 2016

  To inform users about the possible incorrect values for Distance Measurements when using certain modalities in combination with syngo Imaging.

• • Terminated Z-0319-2016 FDA Class II ·initiated 28 Oct 2015

  To provide supplementary information regarding the release of the syngo Imaging Software Version VB36D_HF02. The software provides improvements for all syngo Imaging installations running on the software Version VB36D.

• • Terminated Z-1972-2015 FDA Class II ·initiated 11 Jun 2015

  During certain clinical workflows safety issues may occur involving monitor assignment order and incorrect display and measurements for images with non square pixel size.

• • Terminated Z-1650-2009 FDA Unclassified (pre-2012) ·initiated 1 Jun 2009

  Risk of misinterpretation of patient response to treatment: Date displayed may be incorrect. Filtering based on examination date may lead to an incorrect list of examinations.

510(k) Number

K081734 ↗

FDA Product Code

LLZ

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Syngo.CT Vascular Analysis

  Class II

  FDA 510(k) K112020 Active Cleared 18 Aug 2011

• Acuson SC2000 Diagnostic Ultrasound System

  Class II

  FDA 510(k) K142628 Active Cleared 10 Oct 2014

• Syngo.VIA

  Class II

  FDA 510(k) K123920 Active Cleared 18 Jan 2013

• Syngo.plaza

  Class II

  FDA 510(k) K093612 Active Cleared 4 Mar 2010

• Syngo Dynamics Version 7.0

  Class II

  FDA 510(k) K081018 Active Cleared 25 Apr 2008

• MOBILETT Impact

  Class II

  FDA 510(k) K231577 Active Cleared 25 Jul 2023

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