Xknife 5

• • Terminated Z-1103-2013 FDA Class II ·initiated 10 Dec 2012

  Depending on the system configuration, a software error message in versions 5.0.1 and 5.0.2. occurs if a beam plan is transmitted from XKnife using DICOM-RT.

510(k) Number

K100417 ↗

FDA Product Code

MUJ

Device Class

Class II

Regulation

21 CFR Part 892.5050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K090864 Active Cleared 8 May 2009

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• Integra Selector Ultrasonic Surgical Aspirator System with Bone Tip

  Unclassified

  FDA 510(k) K071669 Active Cleared 17 Aug 2007

See all devices from Integra Radionics, Inc. →