Dmlc IV-Ergo

• • Terminated Z-2157-2013 FDA Class II ·initiated 15 Aug 2013

  Clinical mistreatment may occur when there are errors in the clinical workflow, or settings are incorrect.

• • Terminated Z-0978-2014 FDA Class II ·initiated 1 May 2013

  It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems

• • Terminated Z-0014-2012 FDA Unclassified (pre-2012) ·initiated 25 May 2011 ·on shared 510(k) K001163

  It is possible to load different patients in the record and verify (R&V) system and in the multilead control software (MCS).

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K001163 ↗

FDA Product Code

IXI

Device Class

Class II

Regulation

21 CFR Part 892.5710

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Dynatrac, Cod. 50-1A

  Class II

  FDA 510(k) K034051 Active Cleared 5 Apr 2004

• Evtool Model # V. 1.0

  Class II

  FDA 510(k) K013535 Active Cleared 18 Jan 2002

• Ergo Srs

  Class II

  FDA 510(k) K031281 Active Cleared 23 Dec 2003

• 3D Line Sterotactic Hardware Accessories

  Class II

  FDA 510(k) K011255 Active Cleared 20 Dec 2001

• Stereotactic Body Frame, Model Cod. 70-1A

  Class II

  FDA 510(k) K031631 Active Cleared 18 Jul 2003