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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 a medical device manufactured by Hyperfine Research, Inc.. It received FDA 510(k) clearance on 2020-02-06 under approval 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. It is manufactured by Hyperfine Research, Inc.. The 510(k) number is K192002.

When was Lucy Point-of-Care Magnetic Resonance Imaging Device approved by the FDA?

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

What company makes Lucy Point-of-Care Magnetic Resonance Imaging Device?

Lucy Point-of-Care Magnetic Resonance Imaging Device is manufactured by Hyperfine Research, Inc..

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.

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Related PubMed Literature

PMID: 42204020 A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows. Journal of imaging informatics in medicine (2026) PMID: 42024289 Signal Detection Using Change Point Analysis to Identify Safety Signals from Spontaneous Reports in Aortic Stent Grafts in Japan. Journal of medical systems (2026) PMID: 41938602 AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance. Frontiers in digital health (2026) PMID: 41572440 Regulating Medical Devices: The Values and Politics of the US FDA Review Process. The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

Other Devices by Hyperfine Research, Inc.

K201722Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System K202414BrainInsight

Related Devices (Code: LNH)

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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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