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AIRIS II

by Hitachi Medical Systems America, Inc. 2 variants

510(k) K994378

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 NumberK994378 Date7 Mar 2000ClearedStatusActive

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  • Withdrawn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, 19 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 AIRIS II is a Magnetic Resonance, Specialty Coil designed for MRI systems, intended to enhance imaging of shoulder articular anatomy and large joints. It functions as a radiofrequency (RF) coil to capture magnetic resonance signals, improving signal-to-noise ratio and spatial resolution in targeted regions.

Supplied as a reusable accessory for MRI systems, the AIRIS II coil is intended for use in radiology settings. It is not classified as single-use and requires proper cleaning and maintenance per manufacturer guidelines. The device is MRI-safe and compatible with Hitachi AIRIS MRI systems, with regulatory clearance under FDA 510(k) (K994378). Storage and handling must adhere to MRI equipment protocols to ensure performance and safety.

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Questions

AI-generated answers, 19 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 primary purpose of the AIRIS II coil in MRI imaging and which anatomical regions does it target?

    The AIRIS II is a specialty magnetic resonance coil designed to enhance MRI imaging by improving the signal-to-noise ratio and spatial resolution. It is specifically intended for capturing high-quality images of shoulder articular anatomy and large joints, making it ideal for detailed visualization of these areas during radiology procedures.

  • Is the AIRIS II coil reusable, and what maintenance does it require?

    Yes, the AIRIS II coil is supplied as a reusable accessory for MRI systems. It requires proper cleaning and maintenance following the manufacturer’s guidelines to ensure optimal performance and longevity. Since it is not single-use, adherence to these protocols is essential for safe and effective reuse.

  • Which MRI systems is the AIRIS II coil compatible with, and what regulatory clearance does it hold?

    The AIRIS II coil is designed for compatibility with Hitachi AIRIS MRI systems. It holds FDA clearance under the 510(k) pathway, with the specific clearance number K994378, indicating it has been deemed substantially equivalent to a legally marketed predicate device.

  • Are there multiple models or sizes available for the AIRIS II coil, and how should it be stored?

    The AIRIS II coil comes in multiple models or variants, as indicated by the extensive list of registration numbers (e.g., 3009529630, 3027339477, etc.), which may correspond to different configurations or versions. Storage must follow MRI equipment protocols to maintain performance and safety, as improper handling could compromise imaging quality or pose risks during use.