Question 1

What types of medical devices does Change Healthcare Canada Company manufacture?

Accepted Answer

Change Healthcare Canada Company specializes in software-based medical devices for radiology and cardiology. Their portfolio includes radiological Picture Archiving and Communication Systems (PACS) for storing, managing, and viewing imaging like X-rays, CT scans, and MRIs. They also develop computer systems tailored for cardiac catheterization labs, cardiac mapping, cardiology information systems, and hemodynamics monitoring. These solutions are designed to streamline workflows by integrating diagnostic imaging, procedural data, and patient records.

Question 2

Where is Change Healthcare Canada Company based, and how does that affect its regulatory oversight?

Accepted Answer

Change Healthcare Canada Company is based in the United States, which means its devices fall under FDA jurisdiction. Since the company’s products are Class II devices, they are regulated through pathways like the 510(k) premarket notification process and the Unique Device Identifier (UDI) system. The FDA maintains registries for these devices, ensuring compliance and transparency in the medical device market.

Question 3

Which regulatory registries list Change Healthcare Canada Company’s devices?

Accepted Answer

Change Healthcare Canada Company’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. The 510(k) registry documents premarket notifications for Class II devices, while the UDI system ensures standardized identification and traceability of medical devices in the U.S. market. These registries help healthcare providers and regulators verify the authorized status of specific products.

Question 4

How are Change Healthcare Canada Company’s devices classified under FDA regulations?

Accepted Answer

Change Healthcare Canada Company’s devices are classified as Class II under FDA regulations. This classification applies to products that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. Class II devices typically require premarket submissions like 510(k) notifications to demonstrate substantial equivalence to a legally marketed predicate device, ensuring they meet regulatory standards before entering the market.

Device	Model / Reference	Registries	Class	Status
Change Healthcare Cardiology	15.1	FDA UDI	Class II	Active
McKesson Radiology	12.3	FDA UDI	Class II	Active
Change Healthcare Stratus Imaging PACS	1.4.3	FDA UDI	Class II	Unknown
Change Healthcare Cardiology Hemodynamics	15.1.1	FDA UDI	Class II	Active
Change Healthcare Enterprise Viewer	2.0	FDA UDI	Class II	Active
Change Healthcare Radiology Solutions	12.4.1	FDA UDI	Class II	Active
Change Healthcare Cardiology Hemo	14.3.2	FDA UDI	Class II	Active
Change Healthcare Enterprise Imaging Network™ Viewer	1.0.7	FDA UDI	Class II	Unknown
Change Healthcare Stratus Imaging PACS	1.2.0	FDA UDI	Class II	Unknown
Change Healthcare Stratus Imaging PACS	1.0.1	FDA UDI	Class II	Unknown
McKesson Radiology	12.3	FDA UDI	Class II	Active
Change Healthcare Enterprise Viewer	2.1.1	FDA UDI	Class II	Active
Change Healthcare Cardiology Hemodynamics	15.0.1	FDA UDI	Class II	Active
McKesson Cardiology	14.0	FDA UDI	Class II	Active
Change Healthcare Enterprise Imaging Network Viewer	1.0.3	FDA UDI	Class II	Unknown
Change Healthcare Radiology Solutions	14.0	FDA UDI	Class II	Active
Change Healthcare Stratus Imaging PACS	1.4.8	FDA UDI	Class II	Active
Change Healthcare Stratus Imaging Viewer	1.0.10	FDA UDI	Class II	Unknown
Change Healthcare Stratus Imaging Viewer	1.0.20	FDA UDI	Class II	Active
Change Healthcare Enterprise Imaging Network™ Viewer	1.0.5	FDA UDI	Class II	Unknown
Change Healthcare Anatomical AI™	1.0.0	FDA UDI	Class II	Active
Change Healthcare Enterprise Imaging Network Viewer	1.0.1	FDA UDI	Class II	Unknown
Change Healthcare Cardiology Hemodynamics	15.1	FDA UDI	Class II	Active
Change Healthcare Cardiology ECG Management	15.1	FDA UDI	Class II	Active
Change Healthcare Cardiology ECG Management	14.2	FDA UDI	Class II	Active
Change Healthcare Cardiology Hemo	14.3	FDA UDI	Class II	Active
McKesson Radiology	12.2.2	FDA UDI	Class II	Active
Change Healthcare Stratus Imaging PACS	1.3.0	FDA UDI	Class II	Unknown
Change Healthcare Cardiology Hemo	15.1	FDA UDI	Class II	Active
Change Healthcare Enterprise Imaging Network™ Viewer	1.0.2	FDA UDI	Class II	Unknown
Conserus Enterprise Viewer	2.2.0	FDA UDI	Class II	Active
Change Healthcare Mammography Plus	14.2	FDA UDI	Class II	Active
Change Healthcare Stratus Imaging PACS	1.4.7	FDA UDI	Class II	Unknown
Change Healthcare Enterprise Imaging Network™ Viewer	1.0.6	FDA UDI	Class II	Unknown
McKesson Cardiology Hemo	14.0	FDA UDI	Class II	Active
Change Healthcare Stratus Imaging PACS	1.4.1	FDA UDI	Class II	Unknown
Conserus Enterprise Viewer Mobile	1.1	FDA UDI	Class II	Unknown
McKesson Cardiology ECG Management	14.0	FDA UDI	Class II	Active
Change Healthcare Stratus Imaging PACS	1.1.1	FDA UDI	Class II	Unknown
Change Healthcare Stratus Imaging PACS	0.6.0	FDA UDI	Class II	Unknown
Change Healthcare Cardiology Hemo	15.0.1	FDA UDI	Class II	Active
Change Healthcare Cardiology	15.0.1	FDA UDI	Class II	Active
Change Healthcare Cardiology Hemo	15.0	FDA UDI	Class II	Active
Change Healthcare Cardiology ECG Management	15.1.1	FDA UDI	Class II	Active
Change Healthcare Cardiology Hemo	14.2	FDA UDI	Class II	Active
Change Healthcare Cardiology	15.1.1	FDA UDI	Class II	Active
Change Healthcare Stratus Imaging PACS	0.7.0	FDA UDI	Class II	Unknown
Change Healthcare Stratus Imaging Viewer	1.0.14	FDA UDI	Class II	Unknown
Change Healthcare Enterprise Viewer	14.2	FDA UDI	Class II	Active
McKesson Radiology	12.2.3	FDA UDI	Class II	Active

Change Healthcare Canada Company

What Change Healthcare Canada Company makes

Frequently asked questions

Information

Catalogue (100)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities

FDA Establishments (1)