Name: Predicase
Price: 199 USD

K-number	K201722
Device name	Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
Applicant	Hyperfine Research, Inc.
Product code	LNH
Device class	Class II
Decision date	Aug 11, 2020
Decision	Substantially Equivalent
Regulation	892.1000

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Source

View the full FDA submission: accessdata.fda.gov

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

Everything you need for a 510(k) submission. Nothing you don't.