Axiom Sireskop Sd

• • Ongoing Z-1000-2023 FDA Class II ·initiated 9 Dec 2022 ·on shared 510(k) K051602

  There is potential for the footrest to detach from the patient table during use.

• • Terminated Z-1421-2011 FDA Unclassified (pre-2012) ·initiated 14 Jan 2011 ·on shared 510(k) K051602

  Firm became aware of a potential malfunction and possible hazard to patients in the event the tilt buttons on the OPTI Grip become stuck under the housing

• • Terminated Z-2222-2010 FDA Unclassified (pre-2012) ·initiated 13 Jul 2010 ·on shared 510(k) K051602

  Fluid may enter the multi-functional handle (Opti Grip) when using the Axiom Luminos TF or Sireskop SD system, causing unintended reaction or movement, increased radiation or useless images.

• • Terminated Z-1254-2009 FDA Unclassified (pre-2012) ·initiated 8 Jan 2009 ·on shared 510(k) K051602

  During interventional use and applications, the possibility exists for liquids to enter the systems.

• • Terminated Z-0101-2009 FDA Unclassified (pre-2012) ·initiated 12 Aug 2008 ·on shared 510(k) K051602

  Liquids may enter the system and cause potential malfunction and possible hazard to patients, user or other persons.

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

510(k) Number

K051602 ↗

FDA Product Code

JAA

Device Class

Class II

Regulation

21 CFR Part 892.1650

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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