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FDA 510(k)

Swoop Portable MR Imaging System

K-Number: K221393 · 2022-06-10

ApplicantHyperfine, Inc.
Decision Date2022-06-10
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Swoop Portable MR Imaging System is a medical device manufactured by Hyperfine, Inc.. It received FDA 510(k) clearance on 2022-06-10 under approval number K221393. 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 Portable MR Imaging System?

Swoop Portable MR Imaging System is a medical device that received FDA 510(k) clearance on 2022-06-10. It is manufactured by Hyperfine, Inc.. The 510(k) number is K221393.

When was Swoop Portable MR Imaging System approved by the FDA?

Swoop Portable MR Imaging System received FDA 510(k) clearance on 2022-06-10, under approval number K221393.

What company makes Swoop Portable MR Imaging System?

Swoop Portable MR Imaging System is manufactured by Hyperfine, Inc..

What is the FDA product code for Swoop Portable MR Imaging System?

The FDA product code for Swoop Portable MR Imaging System is LNH.

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Related PubMed Literature

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Other Devices by Hyperfine, Inc.

K212456Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System K211818Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System K223268BrainInsight K223247Swoop Portable MR Imaging System K221923Swoop Portable MR Imaging System K220815BrainInsight

View all 13 devices →

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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