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FDA 510(k)

Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System

K-Number: K211818 · 2021-07-07

ApplicantHyperfine, Inc.
Decision Date2021-07-07
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner 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 2021-07-07 under 510(k) number K211818. 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 Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System?

Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System is a medical device that received FDA 510(k) clearance on 2021-07-07. The listed applicant is Hyperfine, Inc.. The 510(k) number is K211818.

When did Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System receive FDA 510(k) clearance?

Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System received FDA 510(k) clearance on 2021-07-07, under 510(k) number K211818.

Who is the listed applicant for Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner 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 Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System?

The FDA product code for Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner 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.

NCT04436068Hyperfine Portable MRI in Hydrocephalus and Other Conditions Prompting Outpatient Brain ImagingCOMPLETEDNCT07296263Evaluation of Gadolinium Based Contrast Agents for Portable MR Imaging SystemsENROLLING_BY_INVITATIONNCT02422550Imaging Acquisition and Analysis Methods for Optimization of MRI Radiation Oncology Simulation and Response AssessmentRECRUITINGNCT05596591Focused Extracorporeal Shockwave Therapy for Knee ArthritisRECRUITINGNCT00397111Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety DisordersRECRUITINGNCT00453505Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous SystemCOMPLETED

Related PubMed Literature

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.

PMID: 37191776US regulatory considerations for low field magnetic resonance imaging systems.Magma (New York, N.Y.) (2023)

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™

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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