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uMC 560i

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K183144
510(k) Type
Traditional
Applicant
Shanghai United Imaging Healthcare Co.,Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
12/19/2019
Days to Decision
401 days
Submission Type
Summary

uMC 560i

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K183144
510(k) Type
Traditional
Applicant
Shanghai United Imaging Healthcare Co.,Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
12/19/2019
Days to Decision
401 days
Submission Type
Summary