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Swoop® Portable MR Imaging System™

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230208
510(k) Type
Special
Applicant
Hyperfine, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/22/2023
Days to Decision
28 days
Submission Type
Summary