Xplan-2 with Head and Neck Localizer, Model Hnl

• • Terminated Z-1020-04 FDA Unclassified (pre-2012) ·initiated 25 May 2004

  Software may provide inaccurate coordinates and cause mistreatment

510(k) Number

K991237 ↗

FDA Product Code

MUJ

Device Class

Class II

Regulation

21 CFR Part 892.5050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Radionics Disposable Rf Cannulae (Sc-C, Rfk-Db, Rfk-Ds)

  Class II

  FDA 510(k) K980430 Active Cleared 16 Mar 1998

• Rfg-3CF

  Class II

  FDA 510(k) K965182 Active Cleared 12 Mar 1997

• Radionics Microelectrode Kit

  Class II

  FDA 510(k) K991399 Active Cleared 21 Sep 1999

• Radionics Xdc External Ventricular Catheter

  Class II

  FDA 510(k) K992379 Active Cleared 8 Sep 1999

• Ocular-Biometer 4000

  Class II

  FDA 510(k) K820042 Active Cleared 22 Jul 1982

• Pace-1A Cardiac Stimulator

  Class II

  FDA 510(k) K963579 Active Cleared 8 Nov 1996

See all devices from Radionics, Inc. →