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Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201722
510(k) Type
Traditional
Applicant
Hyperfine Research, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/11/2020
Days to Decision
49 days
Submission Type
Summary