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FDA 510(k)

Swoop Portable MR Imaging System

K-Number: K223247 · 2022-12-06

ApplicantHyperfine, Inc.
Decision Date2022-12-06
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 2022-12-06 under 510(k) number K223247. 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 2022-12-06. The listed applicant is Hyperfine, Inc.. The 510(k) number is K223247.

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

Swoop Portable MR Imaging System received FDA 510(k) clearance on 2022-12-06, under 510(k) number K223247.

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.

K253489Swoop® Portable MR Imaging® SystemK250236Swoop® Portable MR Imaging® System (V2)K251276Swoop® Portable MR Imaging® SystemK240944Swoop® Portable MR Imaging® SystemK232760Swoop® Portable MR Imaging System®K230208Swoop® Portable MR Imaging System™

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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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