Lucy Point-of-Care Magnetic Resonance Imaging Device— 510(k) K192002

Name: FDA 510(k) clearance K192002
Creator: U.S. Food and Drug Administration
Published: 2020-02-06

Substantially Equivalent

Hyperfine Research, Inc.

FDA 510(k) clearance K192002 for Lucy Point-of-Care Magnetic Resonance Imaging Device, Substantially Equivalent on 2020-02-06. Applicant: Hyperfine Research, Inc.. Device class: 2.

Clearance details

Applicant: Hyperfine Research, Inc.
Product code: Product code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2019-07-26
Decision date: 2020-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guildford, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LNH

view all

K262902 — ECHELON Synergy2026-10-09
K260092 — Vista AI Scan2026-10-07
K261612 — SwiftSight-BodyComposition2026-10-01
K261283 — APERTO Lucent MRI System2026-09-16
K261758 — Embrace Vision Neonatal MRI System2026-09-16

More clearances from Hyperfine Research, Inc.

view all

K202414 — BrainInsight2021-01-07
K201722 — Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System2020-08-11

Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.