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Magnetic Resonance Diagnostic Device, Airis II

by Hitachi Medical Systems America, Inc.

510(k) K984278

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK984278 Date11 Dec 1998ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MOS
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Magnetic Resonance Diagnostic Device, Airis II is a medical imaging system that uses magnetic fields and radio waves to generate detailed images of internal body structures. It is designed for diagnostic imaging in radiology applications, utilizing magnetic field gradients and RF pulses to encode spatial information.

The device is supplied as a stationary MRI system with various RF coil options including the QD Multiple Array Shoulder Coil and CTL Phased Array Coil. It is authorized under FDA 510(k) clearance with product code MOS and is intended for use in clinical settings. The system supports multiple imaging modes and is designed for continuous imaging of various anatomical regions including the shoulder, cervical, thoracic, and lumbar spine.

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Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Airis II Magnetic Resonance Diagnostic Device used for?

    The Airis II is a medical imaging system designed for diagnostic imaging in radiology applications. It uses magnetic fields and radio waves to generate detailed images of internal body structures, supporting continuous imaging of various anatomical regions including the shoulder, cervical, thoracic, and lumbar spine.

  • What RF coil options are available with the Airis II system?

    The Airis II is supplied as a stationary MRI system with various RF coil options including the QD Multiple Array Shoulder Coil and CTL Phased Array Coil. These coils are designed to optimize image quality for different anatomical regions.

  • What is the regulatory status of the Airis II MRI system?

    The Airis II Magnetic Resonance Diagnostic Device is authorized under FDA 510(k) clearance with product code MOS. It has been determined to be substantially equivalent to predicate devices for its intended use in clinical settings.

  • What are the key features of the Airis II MRI system?

    The Airis II is designed for continuous imaging of various anatomical regions and supports multiple imaging modes. It utilizes magnetic field gradients and RF pulses to encode spatial information, providing detailed diagnostic images for radiology applications.