Swoop® Portable MR Imaging® System
K-Number: K253489 · 2025-12-12
ApplicantHyperfine, Inc.
Decision Date2025-12-12
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 2025-12-12 under approval number K253489. 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 2025-12-12. It is manufactured by Hyperfine, Inc.. The 510(k) number is K253489.
When was Swoop® Portable MR Imaging® System approved by the FDA?
Swoop® Portable MR Imaging® System received FDA 510(k) clearance on 2025-12-12, under approval number K253489.
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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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.