K-number	K212456
Device name	Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
Applicant	Hyperfine, Inc.
Product code	LNH
Device class	Class II
Decision date	Nov 17, 2021
Decision	Substantially Equivalent
Regulation	892.1000

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Source

View the full FDA submission: accessdata.fda.gov

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Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System

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