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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 a medical device manufactured by Hyperfine Research, Inc.. It received FDA 510(k) clearance on 2020-08-11 under approval 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. It is manufactured by Hyperfine Research, Inc.. The 510(k) number is K201722.

When was Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System approved by the FDA?

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

What company makes Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System?

Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System is manufactured by Hyperfine Research, Inc..

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

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT04345003 MR Elastography Parameters Impact on MR-HIFU Efficacy in Uterine Fibroids COMPLETED NCT06577454 Measuring the Effects of Neurostimulation on Risky and Ambiguous Decision-Making Capacity in People With and Without Substance Use Disorder SUSPENDED NCT07099092 Causal Mechanisms of Odor-Guided Behavior in Humans NOT_YET_RECRUITING NCT00109174 MRS Measurement of Glutamate and GABA Metabolism in Brain RECRUITING NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING

Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41271017 Lymphedema Imaging and AI: A Review of Diagnostic Modalities, Biomarkers, and Clinical Integration. Biomedical journal (2025) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Other Devices by Hyperfine Research, Inc.

K192002Lucy Point-of-Care Magnetic Resonance Imaging Device K202414BrainInsight

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Official Source

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