Magnetic Resonance Device Accessory Sm Parts Coil

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

510(k) Number

K910220 ↗

FDA Product Code

LNH

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Opart, Model Mrt-600

  Class II

  FDA 510(k) K991740 Active Cleared 2 Aug 1999

• Mrt 50A Flexible Body Coil

  Class II

  FDA 510(k) K900285 Active Cleared 9 Mar 1990

• Mrt-50

  Class II

  FDA 510(k) K921413 Active Cleared 14 Aug 1992

• Flexart V3.5 Software

  Class II

  FDA 510(k) K970573 Active Cleared 21 Jul 1997

• Mrt 50A Joint Coil

  Class II

  FDA 510(k) K900727 Active Cleared 9 Mar 1990

• Mrt 50A

  Class II

  FDA 510(k) K903770 Active Cleared 20 Nov 1990

See all devices from Toshiba America Mri, Inc. →

• What is the magnetic resonance device accessory, small parts coil, used for?

  The magnetic resonance device accessory, small parts coil, is designed to enhance signal reception for small anatomical structures during MRI procedures. It functions as a component of the imaging apparatus to improve image quality when scanning small body parts, such as hands, feet, or joints, by acting as a specialized radiofrequency receiver coil that works with nuclear magnetic resonance imaging systems.

• Is the small parts coil supplied sterile or non-sterile, and is it intended for single-use or reuse?

  The small parts coil is supplied as a non-sterile component and is intended for reuse. It is designed for multiple uses in radiology settings after appropriate cleaning and disinfection between patients, as indicated by its classification as a reusable accessory rather than a single-use disposable device.

• How is the small parts coil regulated, and what is its FDA clearance status?

  The small parts coil is regulated as a Class II medical device under FDA regulation 892.1000 and has received FDA 510(k) clearance under K910220. It was determined to be substantially equivalent to a legally marketed device, with the clearance granted through a traditional 510(k) submission process, and it is not described as having any other form of approval or marketing authorization beyond this clearance.