MT/S Spine Transmit Coil

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K884606 ↗

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 II

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• Cw Doppler 2.25 Mhz Probe

  Class II

  FDA 510(k) K903562 Active Cleared 2 Mar 1992

• Diasonics Drf-200 Ultrasound Imaging System

  Class II

  FDA 510(k) K851860 Active Cleared 31 Oct 1985

• Diasonics, Berger Stereotactic Neorobiopsy

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  FDA 510(k) K851973 Active Cleared 26 Jul 1985

• Adms Transrectal 7.5 Mhz Probe

  Class II

  FDA 510(k) K870967 Active Cleared 29 Sep 1987

• Cfm-800 Color Flow Mapping System

  Class II

  FDA 510(k) K924079 Active Cleared 28 Sep 1993

See all devices from Diasonics, Inc. →

• What is the MT/S Spine Transmit Coil used for?

  The MT/S Spine Transmit Coil is designed specifically for Nuclear Magnetic Resonance Imaging (MRI) systems to generate the radiofrequency magnetic field needed for signal excitation during spinal imaging. It is optimized for use in the lumbar and thoracic spine regions, improving image quality and diagnostic clarity in these areas.

• Is the MT/S Spine Transmit Coil single-use or reusable?

  The MT/S Spine Transmit Coil is a reusable component for MRI systems. It is not intended for single-use and must be cleaned and maintained according to the manufacturer’s instructions to ensure proper functionality and longevity.

• Is the MT/S Spine Transmit Coil sterile?

  No, the MT/S Spine Transmit Coil is not sterile. It is supplied as a reusable device and requires cleaning and maintenance as part of its lifecycle to prevent contamination and ensure reliable performance.

• What regulatory pathway was followed for the MT/S Spine Transmit Coil?

  The MT/S Spine Transmit Coil received FDA 510(k) clearance under the Traditional 510(k) pathway, with a clearance number of K884606. This pathway demonstrates that the device is substantially equivalent to a legally marketed predicate device.

• How should the MT/S Spine Transmit Coil be stored?

  While the device data does not specify storage conditions explicitly, reusable MRI coils like the MT/S Spine Transmit Coil should generally be stored in a clean, dry environment away from direct sunlight, extreme temperatures, and sources of electromagnetic interference. Always follow the manufacturer’s guidelines for proper handling and storage to maintain performance and integrity.