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FDA 510(k)

Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System

K-Number: K201722 · 2020-08-11

ApplicantHyperfine Research, Inc.
Decision Date2020-08-11
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Hyperfine 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 Research, Inc.. It received FDA 510(k) clearance on 2020-08-11 under 510(k) number K201722. 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 Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System?

Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System is a medical device that received FDA 510(k) clearance on 2020-08-11. The listed applicant is Hyperfine Research, Inc.. The 510(k) number is K201722.

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

Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System received FDA 510(k) clearance on 2020-08-11, under 510(k) number K201722.

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

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

What is the FDA product code for Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System?

The FDA product code for Hyperfine 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 ImagingCOMPLETEDNCT02422550Imaging 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 SystemCOMPLETEDNCT02193425Reliability of the Human Brain ConnectomeCOMPLETED

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 Research, 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.

K202414BrainInsightK192002Lucy Point-of-Care Magnetic Resonance Imaging Device

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

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