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

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

510(k) Number

K103365 ↗

FDA Product Code

MOS

Models / Variants

Discovery 3T 16 Ch Body Array Coil (Anterior)

Discovery 3T 16 Ch Body Array Coil (Posterior)

Discovery 3T 32 Ch Body A

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

• 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.) →

• Are these coils designed for single-use or can they be reused in an MRI setting?

  These coils are not single-use—they are explicitly described as reusable components for MRI systems. However, they require proper cleaning and maintenance as outlined in the manufacturer’s guidelines to ensure performance and safety. Since they are not sterile, they must be handled according to clinical protocols for reusable medical devices.

• What field strength is this coil optimized for, and how does that affect imaging quality?

  The coils are specialty magnetic resonance coils designed for high-field (3 Tesla) MRI systems. Operating at 3T enhances signal reception from the body’s anterior and posterior regions, which improves image resolution and contrast compared to lower-field systems. This makes them ideal for detailed radiologic examinations where high clarity is critical.

• How do I determine which coil variant (16-channel or 32-channel) is best suited for my clinical needs?

  The choice between the 16-channel (anterior/posterior) and 32-channel body array coils depends on your imaging requirements. The 16-channel coils are designed for standard high-resolution imaging, while the 32-channel variant offers even greater parallel imaging capabilities, reducing scan time and improving signal-to-noise ratio for complex or large-volume studies. Consult your radiology team to assess which channel count aligns with your workflow and patient load.

• Do these coils come pre-sterilized, or do I need to handle them with specific sterilization protocols?

  The coils are not sterile and are supplied as reusable components. They require proper cleaning and maintenance per the manufacturer’s guidelines to prepare them for use. Sterilization is not applicable, as they are designed for repeated clinical use in MRI environments. Always follow institutional protocols for reusable medical devices to ensure safety and functionality.

• What regulatory pathways have these coils undergone, and how does that impact their use in my facility?

  These coils have undergone FDA 510(k) clearance and comply with the EU Medical Device Regulation (MDR). The FDA classified them as Class II devices, and they were determined to be substantially equivalent to a predicate device through a traditional review process. This means they meet established safety and performance standards for specialty MRI coils, but your facility should verify compliance with local regulations and institutional policies before integration into your MRI system.