Apex Helix - a

• • Terminated Z-1789-2013 FDA Class I ·initiated 13 Jun 2013

  GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System.

510(k) Number

K914807 ↗

FDA Product Code

KPS

Device Class

Class II

Regulation

21 CFR Part 892.1200

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Gyrex 2T Prestige Model No. 100-6321-0107 and Gyrex Privilege Model No. 100-6326-0102

  Class II

  FDA 510(k) K965044 Active Cleared 16 Jun 1997

• Head and Neck Coil for the Gyrex 2T-Dlx

  Class II

  FDA 510(k) K943320 Active Cleared 29 Nov 1994

• Dynex-44 Diagnostic Ultrasound Imaging

  Class II

  FDA 510(k) K812014 Active Cleared 16 Sep 1981

• Gyrex Privilege

  Class II

  FDA 510(k) K954039 Active Cleared 24 Nov 1995

• 2T Prestige(100-6321-0107)/Privilege(100-6326-0102)/Gyrex V-Ep(100-6327-0101)

  Class II

  FDA 510(k) K972592 Active Cleared 15 Sep 1997

• Ultrasound Equipment Model Sdl-100A

  Not classified

  FDA 510(k) K837084 Active Cleared 28 Apr 1983

See all devices from Elscint, Inc. →