GE 0.2T Signa Profile Excite MR System

• • Terminated Z-1209-2013 FDA Class II ·initiated 8 Jun 2012

  GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. The axial and coronal reformatted images from a sagittal 3D series (such as with applications of FSPGR-3D T1, BRAVO T1, or CUBE T1) of over 126 slices may display a left-to-right image flip . In addition, the acquired sagittal images may be annotated with left-right location annotation revers

510(k) Number

K043112 ↗

FDA Product Code

LNH

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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  Class I

  FDA 510(k) K802548 Active Cleared 2 Dec 1980

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  Class II

  FDA 510(k) K103485 Active Cleared 6 Oct 2011

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  Class II

  FDA 510(k) K110798 Active Cleared 22 Dec 2011

• GE CT/T 8800 System

  Class II

  FDA 510(k) K780326 Active Cleared 14 Mar 1978

• CT Pace Catalog Number B7950A

  Class II

  FDA 510(k) K872526 Active Cleared 23 Sep 1987

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  Class II

  FDA 510(k) K864222 Active Cleared 4 Mar 1987

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