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Airis Elite Magnetic Resonance Imaging Device

by Hitachi Medical Systems America, Inc.

510(k) K032232

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 · Abbreviated NumberK032232 Date29 Sep 2003ClearedStatusActive

Recalls

2 recalls · FDA

    • 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-0890-05 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  • Withdrawn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

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