Sienet Cosmos (Version V15A)

• • Terminated Z-1622-2014 FDA Class II ·initiated 3 Apr 2014

  A complaint reported that the archiving method at one customer site was changed from implicit to explicit, and the cleanup procedure enabled by the explicit archivingmethod may have deleted data from archive itself.

• • Terminated Z-0069-2007 FDA Unclassified (pre-2012) ·initiated 3 Oct 2006

  Potential loss of images. Images may not successfully be sent to the RAID system.

• • Terminated Z-0092-06 FDA Unclassified (pre-2012) ·initiated 22 Sep 2005

  reference lines appear above actual position

510(k) Number

K042832 ↗

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

See all devices from Siemens Medi Cal Solutions, Inc. →