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Change Healthcare Canada Company: FDA-registered device maker in RICHMOND British Columbia, Canada, 37 510(k) clearances

Name: Change Healthcare Canada Company FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Change Healthcare Canada Company is registered with the FDA (registration 8022257) in RICHMOND British Columbia, Canada. It lists 30 device types. The FDA files 37 510(k) clearances under its listings, the newest dated November 12, 2024. 17 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this one Watch Change Healthcare Canada Company

FDA registration number: 8022257
FEI number: 3003757840
Address: 10711 Cambie Road, RICHMOND British Columbia, Canada, V6X 3G5
Owner or operator: Change Healthcare Canada Company (8022257)
Roles: Exporter to the US, Manufacturer, Repackager or relabeler
First device listed: January 26, 2013
Registered through: 2027
Brand names listed: Ambu BlueSensor, Change Healthcare Anatomical AI, Change Healthcare Cardiology, Change Healthcare Cardiology ECG Management, Change Healthcare Cardiology Hemo, Change Healthcare Cardiology Hemodynamics, Change Healthcare Enterprise Viewer, Change Healthcare Mammography Plus and more

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	NHO	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	CBQ	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	CBS	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	NHQ	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	CBR	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Oxygen, Gaseous-Phase	CCL	2	Exporter to the US	accessdata.fda.gov
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	NHP	2	Exporter to the US	accessdata.fda.gov
Automated Radiological Image Processing Software	QIH	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Blood Pressure Cuff	DXQ	2	Exporter to the US	accessdata.fda.gov
Burst Suppression Detection Software For Electroencephalograph	ORT	2	Exporter to the US	accessdata.fda.gov
Cannula, Nasal, Oxygen	CAT	1	Exporter to the US	accessdata.fda.gov
Computer, Diagnostic, Programmable	DQK	2	Manufacturer	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Exporter to the US	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Exporter to the US	accessdata.fda.gov
Electrode, Electrocardiograph	DRX	2	Exporter to the US	accessdata.fda.gov
Full-Montage Standard Electroencephalograph	GWQ	2	Exporter to the US	accessdata.fda.gov
Index-Generating Electroencephalograph Software	OLW	2	Exporter to the US	accessdata.fda.gov
Monitor, Breathing Frequency	BZQ	2	Exporter to the US	accessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	MWI	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	MHX	2	Exporter to the US	accessdata.fda.gov
Non-Normalizing Quantitative Electroencephalograph Software	OLT	2	Exporter to the US	accessdata.fda.gov
Oximeter	DQA	2	Exporter to the US	accessdata.fda.gov
Oximeter, Ear	DPZ	2	Exporter to the US	accessdata.fda.gov
Reduced- Montage Standard Electroencephalograph	OMC	2	Exporter to the US	accessdata.fda.gov
Stethoscope, Esophageal, With Electrical Conductors	BZT	2	Exporter to the US	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Exporter to the US, Manufacturer, Repackager or relabeler	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Exporter to the US	accessdata.fda.gov
System, Tomography, Computed, Emission	KPS	2	Exporter to the US	accessdata.fda.gov
System, X-Ray, Tomography, Computed	JAK	2	Exporter to the US	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 12, 2024	K241981	Change Healthcare Stratus Imaging PACS	LLZ	Substantially Equivalent	Change Healthcare Canada Company	accessdata.fda.gov
August 8, 2024	K240724	SynthVISION 1.0.0	LLZ	Substantially Equivalent	Synthesis Health Intelligence, Inc.	accessdata.fda.gov
September 11, 2023	K230881	Change Healthcare Cardiology Hemodynamics	MWI	Substantially Equivalent	Change Healthcare Israel , Ltd.	accessdata.fda.gov
July 6, 2023	K221056	ARGUS PB-3000	MHX	Substantially Equivalent	Schiller AG	accessdata.fda.gov
January 6, 2022	K213544	TOMTEC-ARENA	QIH	Substantially Equivalent	Tomtec Imaging Systems GmbH	accessdata.fda.gov
October 18, 2021	K212528	Change Healthcare Cardiology	LLZ	Substantially Equivalent	Change Healthcare Israel , Ltd.	accessdata.fda.gov
August 11, 2021	K203643	Sensatronic Reusable Temperature Probes	FLL	Substantially Equivalent	Sensatronic GmbH	accessdata.fda.gov
July 20, 2021	K210719	Change Healthcare Anatomical AI	QIH	Substantially Equivalent	Change Healthcare Canada Company	accessdata.fda.gov
August 14, 2020	K201632	TOMTEC-ARENA	LLZ	Substantially Equivalent	Tomtec Imaging Systems GmbH	accessdata.fda.gov
August 29, 2018	K181185	Change Healthcare Enterprise Viewer	LLZ	Substantially Equivalent	Change Healthcare Canada Company	accessdata.fda.gov
May 24, 2018	K181080	McKesson Cardiology	LLZ	Substantially Equivalent	Change Healthcare Israel , Ltd.	accessdata.fda.gov
November 17, 2017	K171121	Masimo Root Monitoring System and Accessories	MWI	Substantially Equivalent	Masimo Corporation	accessdata.fda.gov
October 18, 2017	K171068	OrthoView 7.2	LLZ	Substantially Equivalent	Meridian Technique, Ltd.	accessdata.fda.gov
August 24, 2016	K161130	ResolutionMD	LLZ	Substantially Equivalent	Calgary Scientific, Inc.	accessdata.fda.gov
August 11, 2015	K151850	McKesson Cardiology	LLZ	Substantially Equivalent	Mckesson Israel , Ltd.	accessdata.fda.gov
February 13, 2015	K150122	TOMTEC-ARENA TTA2	LLZ	Substantially Equivalent	Tomtec Imaging Systems GmbH	accessdata.fda.gov
January 6, 2015	K142850	McKesson Radiology Mammography Plus	LLZ	Substantially Equivalent	Mckesson Medical Imaging Company	accessdata.fda.gov
July 2, 2014	K140909	MCKESSON RADIOLOGY	LLZ	Substantially Equivalent	Mckesson Medical Imaging Company	accessdata.fda.gov
December 5, 2013	K131497	MCKESSON CARDIOLOGY HEMO	MWI	Substantially Equivalent	Mckesson Israel , Ltd.	accessdata.fda.gov
February 22, 2013	K123646	EMORY CARDIAC TOOLBOX 4.0	KPS	Substantially Equivalent	Syntermed, Inc.	accessdata.fda.gov
October 25, 2012	K123043	IRMA C02 MODEL 200101; IRMA AX 200601	CCK	Substantially Equivalent	Phasein AB	accessdata.fda.gov
March 16, 2012	K113515	HORIZON CARDIOLOGY ECG MANAGEMENT	DQK	Substantially Equivalent	Mckesson Israel , Ltd.	accessdata.fda.gov
April 6, 2011	K103604	ISA CO2, ISA AX+, ISA OR+	CCK	Substantially Equivalent	Phasein AB	accessdata.fda.gov
October 21, 2010	K101896	MASIMO LNCS/M-LNCS OXIMETRY SENSORS	DQA	Substantially Equivalent	Masimo Corporation	accessdata.fda.gov
October 4, 2010	K102687	MIRADA RT	LLZ	Substantially Equivalent	Mirada Medical, Ltd.	accessdata.fda.gov
August 4, 2010	K101279	CORRIDOR4DM V2010 MODEL: V2010	LLZ	Substantially Equivalent	Invia	accessdata.fda.gov
August 15, 2008	K080189	TEMPA-KUFF SOFT BLOOD PRESSURE CUFF, MODEL 39XXX ; VINYL,MODEL 99XXX	DXQ	Substantially Equivalent	Trimline Medical Products Corp.	accessdata.fda.gov
March 19, 2008	K073714	TRAUMACAD VERSION 2.0	LLZ	Substantially Equivalent	Orthocrat, Ltd.	accessdata.fda.gov
August 31, 2007	K071584	OASIS RELEASE 1.0	LLZ	Substantially Equivalent	Segami Corporation	accessdata.fda.gov
July 12, 2005	K051212	MODIFICATION TO LNCS OXIMETRY SENSORS	DQA	Substantially Equivalent	Masimo Corporation	accessdata.fda.gov
February 25, 2004	K040214	MODIFICATION TO: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES	DQA	Substantially Equivalent	Masimo Corp.	accessdata.fda.gov
April 8, 2002	K012226	MONITORING SYSTEM,MODEL ARGUS PB-1000	MHX	Substantially Equivalent	Schiller AG	accessdata.fda.gov
April 16, 1998	K980327	MICROSTREAM FILTERLINE ICU	CCK	Substantially Equivalent	Oridion Medical , Ltd.	accessdata.fda.gov
July 24, 1989	K892406	MODIFIED OXYGEN DELIVERY/CO2 SAMPLE NASAL CANNULA	CCK	Substantially Equivalent	Salter Labs	accessdata.fda.gov
January 29, 1988	K874514	HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE	FLL	Substantially Equivalent	Mallinckrodt Critical Care	accessdata.fda.gov
January 19, 1988	K875234	MON-A-THERM'S SKIN TEMPERATURE SENSOR	FLL	Substantially Equivalent	Mon-A-Therm, Inc.	accessdata.fda.gov
July 10, 1981	K811862	HI-LO TEMP ESOPHAGEAL STETHOSCOPE	BZT	Substantially Equivalent	Mallinckrodt Critical Care	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 13, 2025	97545	Class II	Ongoing	Change Healthcare Radiology Solutions software version 14.2.2	Due to software issue, radiology reports may not be fully displayed when viewing.	accessdata.fda.gov
May 22, 2025	97046	Class II	Ongoing	Change Healthcare Cardiology Hemo Software	Due to complaints, software update may cause software to unexpectedly shutdown.	accessdata.fda.gov
August 21, 2024	95284	Class II	Ongoing	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.	accessdata.fda.gov
November 1, 2023	93451	Class II	Ongoing	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.	accessdata.fda.gov
October 12, 2023	93259	Class II	Ongoing	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.	accessdata.fda.gov
April 19, 2021	87891	Class II	Ongoing	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.	accessdata.fda.gov
March 17, 2021	87616	Class II	Ongoing	Change Healthcare Enterprise Viewer	Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display.	accessdata.fda.gov
August 25, 2020	86401	Class II	Terminated	Change Healthcare Radiology Solutions 14.0	Software defect which may potentially result in one or more images missing in a study	accessdata.fda.gov
February 10, 2020	85068	Class II	Ongoing	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	accessdata.fda.gov
December 2, 2016	76500	Class II	Terminated	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.	accessdata.fda.gov
July 12, 2016	75194	Class II	Terminated	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,	The STAT priority icon was not displayed in the Study List when the study was opened.	accessdata.fda.gov
February 18, 2016	73452	Class II	Terminated	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.	accessdata.fda.gov
May 29, 2014	68431	Class II	Terminated	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	Firm received a complaint that an unreported study performed that day could not be opened from the archive.	accessdata.fda.gov
May 5, 2014	68799	Class II	Terminated	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 as	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.	accessdata.fda.gov
April 17, 2014	68208	Class II	Terminated	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,	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.	accessdata.fda.gov
May 29, 2012	62567	Class II	Terminated	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 m	There is a potential to save reports in RadReport with an Incorrect Final Status.	accessdata.fda.gov
May 7, 2010	55723	Not yet classified	Terminated	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 me	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.	accessdata.fda.gov

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Updated October 2, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.