Mckesson Medical Imaging Company
Country not established
- Devices
- 3
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Mckesson Medical Imaging Company makes
McKesson Medical Imaging Company manufactures medical imaging systems under the HORIZON Medical Imaging brand, including radiology equipment and specialized mammography units like the McKesson Radiology Mammography Plus. These devices are designed for diagnostic imaging in clinical settings, supporting X-ray and breast imaging applications.
The company’s portfolio consists of Class II medical devices, regulated under the FDA’s 510(k) clearance pathway. These products are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. regulatory requirements. The company operates from the United States.
Catalogue
Horizon Medical Imaging Ref K043146
Regimes: 510(k) Registry: 510(k)Mckesson Radiology Ref K140909
Regimes: 510(k) Registry: 510(k)McKesson Radiology Mammography Plus Ref K142850
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Mckesson Medical Imaging Company, initiated on 2016-12-02. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2016
- 2 Dec 2016 Z-1396-2017 Class II Terminated 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.
Frequently asked questions
How many devices does Mckesson Medical Imaging Company have in the registry?
The registry currently lists 3 devices for Mckesson Medical Imaging Company. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mckesson Medical Imaging Company's devices?
Among its 3 most recently registered devices, Mckesson Medical Imaging Company has devices listed in FDA 510(k) (3 devices).
What risk classes do Mckesson Medical Imaging Company's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Mckesson Medical Imaging Company's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Mckesson Medical Imaging Company?
FDA recall records list 1 recall initiated by Mckesson Medical Imaging Company, the most recent initiated on 2 Dec 2016. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Mckesson Medical Imaging Company in the registry?
The most recently registered devices listed for Mckesson Medical Imaging Company include HORIZON MEDICAL IMAGING, MCKESSON RADIOLOGY and McKesson Radiology Mammography Plus.