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Airis II

by Hitachi Medical Systems America, Inc. 2 variants

510(k) K974212

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 closed

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 NumberK974212 Date9 Feb 1998ClearedStatusActive

Recalls

5 recalls · FDA

    • Terminated Z-1104-06 FDA Unclassified (pre-2012) initiated 28 Apr 2006

    Software anomaly-A software defect can cause the slice line indicator to become mis-positioned during Multi-Planar Reconstructions (MPR) with the potential for patient mis-diagnosis.

    • Terminated Z-1115-06 FDA Unclassified (pre-2012) initiated 25 Apr 2006

    Improper Assembly-The AIRIS/AIRIS II MRI system has the potential for the input wiring of a power transformer to overheat due to damaged wiring or possible loose connections.

    • Terminated Z-0910-06 FDA Unclassified (pre-2012) initiated 21 Feb 2006

    The device has a software anomaly which causes the operating system to 'lock up' and data to become corrupted during service procedures.

    • Terminated Z-0429-06 FDA Unclassified (pre-2012) initiated 1 Dec 2005

    The bolts holding the lift mechanism may be damaged causing them to fail and the table top to drop several inches.

    • Terminated Z-0889-05 FDA Unclassified (pre-2012) initiated 30 Jun 2005

    Image reconstruction software problem that could potentially cause multiple patient images to be stored in one patient folder.

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  • Withdrawn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
LNH
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 Airis II is a nuclear magnetic resonance imaging system classified as a Class II medical device. It is designed to provide physicians with physiological and clinical information through imaging procedures.

The device is supplied as a reusable system intended for use in radiology settings. It has received FDA 510(k) clearance under regulation number 892.1000 and product code LNH, with manufacturer Hitachi Medical Systems America, Inc. located in Twinsburg, Ohio.

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