Somatom Spirit

• • Terminated Z-1451-2018 FDA Class II ·initiated 15 Feb 2018

  to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure

• • Terminated Z-1721-2014 FDA Class II ·initiated 21 Mar 2014

  The rubber damper may degrade and break, causing loosening of the motor mounting plates, which could lead to a series of events that could place the operator and patient at risk of injury.

510(k) Number

K042328 ↗

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 P30 CT Systems

  Class II

  FDA 510(k) K013522 Active Cleared 7 Nov 2001

• Somatom Definition Edge

  Class II

  FDA 510(k) K120579 Active Cleared 23 May 2012

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