Dst-Xl

• • Terminated Z-2008-2008 FDA Unclassified (pre-2012) ·initiated 10 Mar 2008

  GE Healthcare has recently became aware of a cable failure associated with the arm or gantry rotation of the DST-XL Camera that may impact patient safety.

• • Terminated Z-0105-06 FDA Unclassified (pre-2012) ·initiated 27 Sep 2005

  Cracked welds on the main rotation shaft could potentially lead to the collapse of the gantry yokes that support the detectors if the system is continued to be used after the weld has completely fractured.

510(k) Number

K942837 ↗

FDA Product Code

KPS

Device Class

Class II

Regulation

21 CFR Part 892.1200

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K921008 Active Cleared 27 Apr 1992

• Sophycamera Dsx Bodytrak Open recall

  Class I

  FDA 510(k) K911346 Active Cleared 18 Apr 1991

• Sophy Nxt

  Class II

  FDA 510(k) K913641 Active Cleared 17 Dec 1991

• Transmission Attenuation Correction (TAC) Package

  Class II

  FDA 510(k) K952190 Active Cleared 18 Jan 1996

• Sophy Series of Nuclear Medicine Computer Systems

  Class I

  FDA 510(k) K872132 Active Cleared 26 Oct 1987

• Ds-7 Nuclear Medicine Gamma Camera

  Class I

  FDA 510(k) K872297 Active Cleared 12 Aug 1987

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