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FDA 510(k)

Swoop® Portable MR Imaging® System (V2)

K-Number: K250236 · 2025-05-30

ApplicantHyperfine, Inc.
Decision Date2025-05-30
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Swoop® Portable MR Imaging® System (V2) is a medical device manufactured by Hyperfine, Inc.. It received FDA 510(k) clearance on 2025-05-30 under approval number K250236. 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 (V2)?

Swoop® Portable MR Imaging® System (V2) is a medical device that received FDA 510(k) clearance on 2025-05-30. It is manufactured by Hyperfine, Inc.. The 510(k) number is K250236.

When was Swoop® Portable MR Imaging® System (V2) approved by the FDA?

Swoop® Portable MR Imaging® System (V2) received FDA 510(k) clearance on 2025-05-30, under approval number K250236.

What company makes Swoop® Portable MR Imaging® System (V2)?

Swoop® Portable MR Imaging® System (V2) is manufactured by Hyperfine, Inc..

What is the FDA product code for Swoop® Portable MR Imaging® System (V2)?

The FDA product code for Swoop® Portable MR Imaging® System (V2) is LNH.

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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

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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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