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FDA 510(k)

Lucy Point-of-Care Magnetic Resonance Imaging Device

K-Number: K192002 · 2020-02-06

ApplicantHyperfine Research, Inc.
Decision Date2020-02-06
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Lucy Point-of-Care Magnetic Resonance Imaging Device 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 2020-02-06 under 510(k) number K192002. 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 Lucy Point-of-Care Magnetic Resonance Imaging Device?

Lucy Point-of-Care Magnetic Resonance Imaging Device is a medical device that received FDA 510(k) clearance on 2020-02-06. The listed applicant is Hyperfine Research, Inc.. The 510(k) number is K192002.

When did Lucy Point-of-Care Magnetic Resonance Imaging Device receive FDA 510(k) clearance?

Lucy Point-of-Care Magnetic Resonance Imaging Device received FDA 510(k) clearance on 2020-02-06, under 510(k) number K192002.

Who is the listed applicant for Lucy Point-of-Care Magnetic Resonance Imaging Device?

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 Lucy Point-of-Care Magnetic Resonance Imaging Device?

The FDA product code for Lucy Point-of-Care Magnetic Resonance Imaging Device 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 ImagingCOMPLETEDNCT05596591Focused Extracorporeal Shockwave Therapy for Knee ArthritisRECRUITINGNCT07277738Precision Supplemental Imaging in Women With Dense BreastsNOT_YET_RECRUITINGNCT07568067Accelerated Temporal Interference Stimulation on Bilateral Subthalamic Nucleus for Parkinson's Disease and Secondary Parkinson's SyndromeRECRUITINGNCT07721688Different Frequency Temporal Interference Stimulation on Bilateral Subthalamic Nucleus for Parkinson's DiseaseRECRUITING

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.

K202414BrainInsightK201722Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System

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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