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Airis

by Hitachi Medical Systems America, Inc. 2 variants

510(k) K945155

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 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 NumberK945155 Date24 May 1995ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-0029-2007 FDA Unclassified (pre-2012) initiated 16 Aug 2006

    Image orientation error. When a 3D Maximum Intensity Projection (MIP) image data set is transferred from the MRI system to a computer workstation via the DICOM protocol, the anatomical markers do not change between the images as they rotate.

    • Terminated Z-1105-06 FDA Unclassified (pre-2012) initiated 17 Mar 2006

    Software anomaly. A software defect in the referenced systems can cause a slice indicator (reference line) to be mis-positioned on the cross-reference image when it is magnified. This image error could result in a possible patient mis-diagnosis.

    • Terminated Z-0428-06 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.

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  • Withdrawn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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