Change Healthcare Canada Company
RICHMOND British Columbia, CA
CHANGE HEALTHCARE CANADA COMPANY appears in FDA device records in RICHMOND British Columbia, CA. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 20 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
3 namesFDA records resolved to Change Healthcare Canada Company carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Mckesson Medical Imaging Company510(k), enforcement report, recall
- Mckesson Medical Imaging Groupenforcement report, recall
- Mckesson Medical Immagingenforcement report, recall
510(k) clearance history
FDA records hold 6 510(k) clearances for Change Healthcare Canada Company between 2005 and 2024. The busiest year on record is 2005, with 1. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2018 | 1 |
| 2021 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K241981 | Change Healthcare Stratus Imaging PACS | LLZ | Substantially Equivalent | |
| K210719 | Change Healthcare Anatomical AI | QIH | Substantially Equivalent | |
| K181185 | Change Healthcare Enterprise Viewer | LLZ | Substantially Equivalent | |
| K142850 | McKesson Radiology Mammography Plus | LLZ | Substantially Equivalent | |
| K140909 | MCKESSON RADIOLOGY | LLZ | Substantially Equivalent | |
| K043146 | HORIZON MEDICAL IMAGING | LLZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8022257 | 3003757840 | CHANGE HEALTHCARE CANADA COMPANY | 10711 CAMBIE ROAD, RICHMOND British Columbia V6X 3G5 CA | 2026 | and 20 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- NHOAnalyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
- CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
- CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
- NHQAnalyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)
- CBRAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- NHPAnalyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
- QIHAutomated Radiological Image Processing Software
- DXQBlood Pressure Cuff
- ORTBurst Suppression Detection Software For Electroencephalograph
- CATCannula, Nasal, Oxygen
- DQKComputer, Diagnostic, Programmable
- FLLContinuous Measurement Thermometer
- GXYElectrode, Cutaneous
- DRXElectrode, Electrocardiograph
- GWQFull-Montage Standard Electroencephalograph
- OLWIndex-Generating Electroencephalograph Software
- BZQMonitor, Breathing Frequency
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- OLTNon-Normalizing Quantitative Electroencephalograph Software
- DQAOximeter
- DPZOximeter, Ear
- OMCReduced- Montage Standard Electroencephalograph
- BZTStethoscope, Esophageal, With Electrical Conductors
- LLZSystem, Image Processing, Radiological
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- KPSSystem, Tomography, Computed, Emission
- JAKSystem, X-Ray, Tomography, Computed
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0030-2026 | Change Healthcare Radiology Solutions software version 14.2.2 | Due to software issue, radiology reports may not be fully displayed when viewing. | Class II | Open, Classified | |
| Z-2072-2025 | Change Healthcare Cardiology Hemodynamics Software | Due to complaints, software update may cause software to unexpectedly shutdown. | Class II | Open, Classified | |
| Z-2071-2025 | Change Healthcare Cardiology Hemo Software | Due to complaints, software update may cause software to unexpectedly shutdown. | Class II | Open, Classified | |
| Z-0128-2025 | McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0. | A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. This issue occurs when the unit of measurement (UOM) for hemoglobin is configured in a way that differs from the users understanding. | Class II | Open, Classified | |
| Z-0127-2025 | Horizon Cardiology Hemo. Version 12.2. | A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. This issue occurs when the unit of measurement (UOM) for hemoglobin is configured in a way that differs from the users understanding. | Class II | Open, Classified | |
| Z-0126-2025 | Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1. | A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. This issue occurs when the unit of measurement (UOM) for hemoglobin is configured in a way that differs from the users understanding. | Class II | Open, Classified | |
| Z-0551-2024 | Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS. | Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient's study. | Class II | Open, Classified | |
| Z-0237-2024 | Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management software. | 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. | Class II | Open, Classified | |
| Z-1773-2021 | Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM medical images, reports, and multimedia content. | A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV. | Class II | Open, Classified | |
| Z-1508-2021 | Change Healthcare Enterprise Viewer | Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display. | Class II | Open, Classified | |
| Z-0072-2021 | Change Healthcare Radiology Solutions 14.0 | Software defect which may potentially result in one or more images missing in a study | Class II | Terminated | |
| Z-1682-2020 | McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management | Inaccurate estimation of the heart rate may occur in instances where the user is estimating heart rate counting grid squares using the Sequential ECG format | Class II | Open, Classified | |
| Z-1396-2017 | McKesson Radiology 12.2 - Picture Archive Communication System (PACS) | 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. | Class II | Terminated | |
| Z-2872-2016 | McKesson Radiology, versions 12.1.1 and 12.2 McKesson Radiology (MR) is a Picture Archiving Communication System (PACS). It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems. | The STAT priority icon was not displayed in the Study List when the study was opened. | Class II | Terminated | |
| Z-1182-2016 | McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1. | 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. | Class II | Terminated | |
| Z-1728-2014 | Horizon Medical Imaging Horizon Medical Imaging is a medical image and information management application that is intended to receive transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems. | Firm received a complaint that an unreported study performed that day could not be opened from the archive. | Class II | Terminated | |
| Z-2121-2014 | Horizon Medical Imaging It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems. | 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. | Class II | Terminated | |
| Z-1617-2014 | McKesson Radiology-PACS. McKesson Radiology is a medical image and information application that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems. | 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. | Class II | Terminated | |
| Z-2238-2012 | Horizon Medical Imaging system. Product Usage: Horizon Medical Imaging is a medical image and information management application that is intended to receive, transmit store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical image systems. The medical modalities of these medical imaging systems include, but are not limited to, all modalities supported by ACR/NEMA DICOM 3.0 (specifically including mammographic images). Horizon Medical Imaging is intended to function with a variety of storage systems and printers via DICOM and other computer industry standard interfaces and protocols. Horizon Medical Imaging is indicated for use by trained medical professionals including, but not limited to, radiologist, physicians, and medical technologists. Horizon Medical Imaging is also indicated for use in soft copy diagnostic interpretation of medical images and video by physicians trained in such practice (specifically including soft copy diagnostic interpretation of mammographic images). | There is a potential to save reports in RadReport with an Incorrect Final Status. | Class II | Terminated | |
| Z-1735-2010 | Voiceware clip software update to certain Horizon Medical Imaging Systems. McKesson Medical Imaging Company. Richmond, Canada V6X 3G5. Intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video and associated medical information from various medical imaging systems. | 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. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain