1.5T GEM RT Open Array

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K123327 ↗

FDA Product Code

MOS

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• 48CH Head Coil

  Class II

  FDA 510(k) K163205 Active Cleared 12 Jan 2017

• 3.0T 16 Channel Head Neck Spine Coil

  Class II

  FDA 510(k) K093348 Active Cleared 25 Nov 2009

• Discovery 3T 16 Ch Body Array Coil (Anterior); Discovery 3T 16 Ch Body Array Coil (Posterior); Discovery 3T 32 Ch Body a

  Class II

  CE/MDR FDA 510(k) K103365 Active Cleared 12 Jan 2011

• Pediatric Positioner Pad Set

  Class I

  FDA 510(k) K122174 Active Cleared 16 Nov 2012

• 3.0T Air 32CH Hna

  Class II

  FDA 510(k) K253738 Active Cleared 23 Jan 2026

• 3.0T GEM RT Open Array

  Class II

  FDA 510(k) K143389 Active Cleared 6 Mar 2015

See all devices from Ge Healthcare Coils (Usa Instruments, Inc.) →

• What is the 1.5T GEM RT Open Array used for?

  The 1.5T GEM RT Open Array is a multi-element phased array RF receive-only coil designed for imaging of the head, neck, and brachial plexus anatomies and vasculature using 1.5T MRI systems manufactured by GE Healthcare.

• How is the 1.5T GEM RT Open Array supplied?

  The device is supplied as a receive-only RF coil with integrated preamplifiers, designed to fit into the GEM table at the head or foot end adjacent to the existing integrated posterior array for use with GE Healthcare 1.5T MRI systems.

• What is the regulatory status of the 1.5T GEM RT Open Array?

  The device is authorized under FDA 510(k) clearance with product code MOS, having been determined substantially equivalent to predicate devices for its intended use in MRI imaging applications.

• Can the 1.5T GEM RT Open Array be reused or is it single-use?

  The device description does not specify whether it is designed for single-use or multiple reuse, as this information is not included in the provided device data.