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Biograph mMR with syngo MR E11P-AP01 system software

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200213
510(k) Type
Traditional
Applicant
Siemens Medical Solutions, USA, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/11/2020
Days to Decision
104 days
Submission Type
Summary

Biograph mMR with syngo MR E11P-AP01 system software

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200213
510(k) Type
Traditional
Applicant
Siemens Medical Solutions, USA, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/11/2020
Days to Decision
104 days
Submission Type
Summary