Somatom Definition

• • Terminated Z-1518-2016 FDA Class II ·initiated 2 Mar 2016

  Software bugs in these SOMATOM systems could possibly cause scan aborts, re-scans of patients with additional dose, delayed diagnosis and as worst case scenarios, could possibly cause the need of additional contrast medium, accidental x-radiation to the user or impede customer workflow.

• • Terminated Z-0907-2014 FDA Class II ·initiated 15 Nov 2013

  During clinical operation, a malfunction may occur causing a system display freeze with SOMATOM Definition, Definition AS, and definition Edge while running software version syngo CT2012 B and syngo CT2013B.

• • Terminated Z-0948-2013 FDA Class II ·initiated 27 Nov 2012

  Sporadic hang-up malfunctions concerning 3D reconstructions during activated "Preview Image" functionality.

510(k) Number

K122471 ↗

FDA Product Code

JAK

Device Class

Class II

Regulation

21 CFR Part 892.1750

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• DynaCT

  Class II

  FDA 510(k) K042646 Active Cleared 19 Oct 2004

• Omnia X/Xs Ultrasound System

  Class II

  FDA 510(k) K020353 Active Cleared 13 Feb 2002

• Somatom Project P30L

  Class II

  FDA 510(k) K040577 Active Cleared 22 Mar 2004

• 6 Channel Body Coil

  Class II

  FDA 510(k) K023571 Active Cleared 20 Nov 2002

• Somatom Spirit

  Class II

  FDA 510(k) K042328 Active Cleared 14 Sep 2004

• Somatom P30 CT Systems

  Class II

  FDA 510(k) K013522 Active Cleared 7 Nov 2001

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