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ECHELON Oval V 5.1 MRI System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153547
510(k) Type
Special
Applicant
Hitachi Medical Systems America, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/31/2016
Days to Decision
111 days
Submission Type
Summary