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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Hyperfine, Inc.. It received FDA 510(k) clearance on 2025-12-12 under 510(k) 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. The listed applicant is Hyperfine, Inc.. The 510(k) number is K253489.

When did Swoop® Portable MR Imaging® System receive FDA 510(k) clearance?

Swoop® Portable MR Imaging® System received FDA 510(k) clearance on 2025-12-12, under 510(k) number K253489.

Who is the listed applicant for Swoop® Portable MR Imaging® System?

The FDA 510(k) record lists Hyperfine, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07296263Evaluation of Gadolinium Based Contrast Agents for Portable MR Imaging SystemsENROLLING_BY_INVITATION

Other records listing Hyperfine, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250236Swoop® Portable MR Imaging® System (V2)K251276Swoop® Portable MR Imaging® SystemK240944Swoop® Portable MR Imaging® SystemK232760Swoop® Portable MR Imaging System®K230208Swoop® Portable MR Imaging System™K223268BrainInsight

View all 13 devices →

Related Devices (Code: LNH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253808AIR Recon DLGE Medical SystemsK261331I-Genius (100019400)Esaote, S.p.A.K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AGK260113uMR AstraShanghai United Imaging Healthcare Co., Ltd.K253862APERTO Lucent MRI SystemFujifilm CorporationK260746S-scan Open (100001800)Esaote, S.p.A.

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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