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Galaxy R Digital Radiography Upgrade

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K172435
510(k) Type
Traditional
Applicant
MEDIEN INTERNATIONAL CO LTD
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
10/13/2017
Days to Decision
63 days
Submission Type
Summary

Galaxy R Digital Radiography Upgrade

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K172435
510(k) Type
Traditional
Applicant
MEDIEN INTERNATIONAL CO LTD
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
10/13/2017
Days to Decision
63 days
Submission Type
Summary