FDA.report

510(k) K142850

Device
McKesson Radiology Mammography Plus
Applicant
MCKESSON MEDICAL IMAGING COMPANY
510(k) number
K142850
Product code
LLZ  
Decision
Substantially Equivalent (SESE)
Decision date
2015-01-06
Date received
2014-09-30
Regulation
892.2050
Classification name
System, Image Processing, Radiological
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
GILBERT WONG
Address
130-10711 Cambie Rd. Richmond, B.C. CA V6X 3G5 V6X 3G5

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
17540262180053Change Healthcare Mammography PlusChange Healthcare Canada Company2025-05-16
17540262180046Change Healthcare Mammography PlusChange Healthcare Canada Company2023-11-10
17540262180022Change Healthcare Mammography PlusChange Healthcare Canada Company2023-06-21
17540262180015Change Healthcare Mammography PlusChange Healthcare Canada Company2023-06-21
17540262180039Change Healthcare Mammography PlusChange Healthcare Canada Company2023-06-20

Legacy Summary

summary

FDA Review

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