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MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191050
510(k) Type
Traditional
Applicant
Siemens Medical Solutions, USA Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/12/2019
Days to Decision
84 days
Submission Type
Summary