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Auto Lung Nodule Detection

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201560
510(k) Type
Traditional
Applicant
Samsung Electronics Co.,Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
8/31/2021
Days to Decision
447 days
Submission Type
Summary

Auto Lung Nodule Detection

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201560
510(k) Type
Traditional
Applicant
Samsung Electronics Co.,Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
8/31/2021
Days to Decision
447 days
Submission Type
Summary