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Mckesson Radiology

by Mckesson Medical Imaging Company

510(k) K140909

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

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 NumberK140909 Date2 Jul 2014ClearedStatusActive

Recalls

4 recalls · 2 ongoing · FDA

    • Ongoing Z-0030-2026 FDA Class II initiated 13 Aug 2025

    Due to software issue, radiology reports may not be fully displayed when viewing.

    • Ongoing Z-0237-2024 FDA Class II initiated 12 Oct 2023

    Change Healthcare has identified a software issue where Change Healthcare Radiology Solutions 14.0, 14.1, and 14.2 may not update records in external applications.

    • Terminated Z-0072-2021 FDA Class II initiated 25 Aug 2020

    Software defect which may potentially result in one or more images missing in a study

    • Terminated Z-1396-2017 FDA Class II initiated 2 Dec 2016

    Issue for customers that use an EMR login or legacy web URL login or legacy web URL login for McKesson Radiology PACS that may result in missing images in a newly imported study, and/or study imports that remain in an "in-progress" status.

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  • Withdrawn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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