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Hitachi Presto

by Hitachi Medical Systems America, Inc.

510(k) K040902

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 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 NumberK040902 Date21 Apr 2004ClearedStatusActive

Recalls

4 recalls · FDA

    • Terminated Z-1651-2009 FDA Unclassified (pre-2012) initiated 14 Apr 2009

    Incorrect scale on image: A software error can occur if two (2) different Field-of-View (FOV) settings are registered in a protocol using Multi-Reconstruction. This could cause the image generated to be displayed with the wrong scale factor rendering anatomical measurements incorrect.

    • Terminated Z-0608-2009 FDA Unclassified (pre-2012) initiated 5 Nov 2008

    Software error: The device has a software error that can result in a condition where the displayed image orientation does not match the display orientation markers (right-left reversal).

    • Terminated Z-1078-06 FDA Unclassified (pre-2012) initiated 21 Feb 2006

    The device has a software anomaly which affects the system's ability to create Multiplanar Reconstructions (MPR). Some images from the resulting series do not display correctly, or display at all, when MPR was run on them.

    • Terminated Z-1079-06 FDA Unclassified (pre-2012) initiated 21 Feb 2006

    The device has a software anomaly which causes blank images to be created during Multiplanar Reconstruction processing or results in an inherent filming error in which a reference scale is improperly sized.

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  • Withdrawn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
JAK
Device Class
Class II
Regulation
21 CFR Part 892.1750
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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