Leksell Surgiplan

• • Terminated Z-1428-2010 FDA Unclassified (pre-2012) ·initiated 23 May 2005

  Images from a different patient can be imported without a warning for the user.

510(k) Number

K943468 ↗

FDA Product Code

HAW

Device Class

Class II

Regulation

21 CFR Part 882.4560

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Es-100 Power System, Es-100 Series

  Class I

  FDA 510(k) K925360 Active Cleared 7 Sep 1993

• Es-100 Accessories

  Class I

  FDA 510(k) K932261 Active Cleared 7 Jan 1994

• Elekta Oncology Systems Precise Treatment Table

  Class II

  FDA 510(k) K983678 Active Cleared 15 Jan 1999

• Spetzler Ti 100 Aneurysm Clip

  Class II

  FDA 510(k) K955064 Active Cleared 17 Oct 1996

• Cmf-Titanium Cranio-Maxillo-Facial Fracture Fixation (Osteosynthesis) System

  Class II

  FDA 510(k) K946165 Active Cleared 23 May 1995

• Leksell Neuro Generator and Accessories

  Class II

  FDA 510(k) K941823 Active Cleared 22 Mar 1996

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