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Horizon Medical Imaging

by Mckesson Medical Imaging Company

510(k) K043146

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

11 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 NumberK043146 Date4 Jan 2005ClearedStatusActive

Recalls

11 recalls · FDA

    • Terminated Z-2872-2016 FDA Class II initiated 12 Jul 2016

    The STAT priority icon was not displayed in the Study List when the study was opened.

    • Terminated Z-1182-2016 FDA Class II initiated 18 Feb 2016

    McKesson has identified a design deficiency where under rare circumstances, imported images/studies may re-use a non-unique image directory. This issue may cause incorrect images to be displayed for a patient.

    • Terminated Z-1728-2014 FDA Class II initiated 29 May 2014

    Firm received a complaint that an unreported study performed that day could not be opened from the archive.

    • Terminated Z-2121-2014 FDA Class II initiated 5 May 2014

    The firm has identified a software issue which may cause a discrepancy between the index of images expected by the application, and the actual content of the folder storing the images.

    • Terminated Z-1617-2014 FDA Class II initiated 17 Apr 2014

    High priority alert icon was not displayed in the Study List when there are no Stat studies present. However, the High priority alert icon is visible when studies marked as Stat priority exist in the Study List.

    • Terminated Z-0976-2014 FDA Class II initiated 23 Dec 2013

    Images may be archived to an incorrect or invalid archive location resulting in incorrect images or no images being displayed for a study following retrieval from archive.

    • Terminated Z-0556-2014 FDA Class II initiated 15 Oct 2013

    When merging two patient records into one patient record using McKesson Radiology 12.0, the resulting patient record is missing the Contrast Allergy information for the second patient record.

    • Terminated Z-2318-2013 FDA Class II initiated 4 Sep 2013

    Software malfunction may occur resulting in a certain combination of server configurations which has the potential to cause image loss.

    • Terminated Z-2238-2012 FDA Class II initiated 29 May 2012

    There is a potential to save reports in RadReport with an Incorrect Final Status.

    • Terminated Z-3035-2011 FDA Unclassified (pre-2012) initiated 2 Feb 2011

    Images for one patient may appear in the study of another patient.

    • Terminated Z-1735-2010 FDA Unclassified (pre-2012) initiated 7 May 2010

    Voice Clip issue: When the user is recording voice clips in Horizon Rad Station, there is a potential for voice clips to be saved to the incorrect study of the same patient.

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
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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