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McKesson Radiology 12.2.2

by Change Healthcare Canada Company

Ref 12.2.2

McKesson Radiology 12.2.2 is a device classified as Class IIa in the EU and Class II in the US made by Change Healthcare Canada Company, registered in EUDAMED on 29 Jul 2026 (Basic UDI-DI B-80010939020020), cleared under FDA 510(k) K140909 on 2 Jul 2014 and listed in FDA GUDID since 21 Feb 2017 (UDI-DI 80010939020020), active as of 23 Oct 2026. 4 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K140909

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-80010939020020 Basic UDI-DI 80010939020020UDI-DIDate29 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number80010939020020 UDI-DI Date21 Feb 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK140909 Date2 Jul 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-80010939020020 registered 29 Jul 2026 Active
  • FDA 510(k) K140909 decided 2 Jul 2014 Active
  • FDA GUDID UDI-DI 80010939020020 listed 21 Feb 2017 Listed

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.

Timeline

7 dated events

  1. Cleared FDA 510(k) K140909
  2. Recall initiated FDA recalls Z-1396-2017
  3. Listed FDA GUDID 80010939020020
  4. Recall initiated FDA recalls Z-0072-2021
  5. Recall initiated FDA recalls Z-0237-2024
  6. Recall initiated FDA recalls Z-0030-2026
  7. Registered EUDAMED B-80010939020020

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
McKesson Radiology
Generic name
Radiological PACS-dedicated management software
Model / reference
12.2.2
Primary DI / UDI-DI
80010939020020
Basic UDI-DI
B-80010939020020
510(k) Number
FDA product code
LLZ
EMDN code
Z110603 Picture archiving and communication systems
GMDN term
Radiological PACS-dedicated management software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2050
EU registration type
Legacy device (under a directive)
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Radiological PACS software

Cleared under the same submission (K140909)

and 5 more cleared under K140909

Similar devices in this category

Other devices filed under PICTURE ARCHIVING AND COMMUNICATION SYSTEMS.

Other devices from Change Healthcare Canada Company

See all devices from Change Healthcare Canada Company →

Properties

  • Measuring function
  • Lot / batch number
Other properties (21, all answered No)