Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
K-Number: K211818 · 2021-07-07
ApplicantHyperfine, Inc.
Decision Date2021-07-07
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System is a medical device manufactured by Hyperfine, Inc.. It received FDA 510(k) clearance on 2021-07-07 under approval number K211818. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System?
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System is a medical device that received FDA 510(k) clearance on 2021-07-07. It is manufactured by Hyperfine, Inc.. The 510(k) number is K211818.
When was Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System approved by the FDA?
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System received FDA 510(k) clearance on 2021-07-07, under approval number K211818.
What company makes Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System?
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System is manufactured by Hyperfine, Inc..
What is the FDA product code for Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System?
The FDA product code for Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System is LNH.
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Official Source
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