3.0T GEM RT Open Array

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

510(k) Number

K143389 ↗

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

• 1.5T GEM RT Open Array

  Class II

  FDA 510(k) K123327 Active Cleared 11 Jan 2013

• 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

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

• What is the 3.0T GEM RT Open Array used for?

  The 3.0T GEM RT Open Array is a magnetic resonance specialty coil designed for use in magnetic resonance imaging systems, specifically intended for radiology applications as indicated in its product classification and intended use description.

• Is the 3.0T GEM RT Open Array sterile or non-sterile, and is it single-use or reusable?

  The device is supplied as a non-sterile, reusable device, meaning it is not provided in a sterile condition and is intended for multiple uses after appropriate cleaning and reprocessing in accordance with manufacturer guidelines.

• What regulatory pathway was used for the 3.0T GEM RT Open Array, and what is its classification?

  The device received FDA 510(k) clearance under submission K143389 and is classified as a Class II medical device, as explicitly stated in the device data, indicating it was found substantially equivalent to a legally marketed predicate device.