Chrysalis Intelligence · Sponsors · Hyperfine Research, Inc.

Hyperfine Research, Inc.

Guildford, CT, US · 3 510(k) clearances

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Total clearances
3
2020-02-06 → 2021-01-07
Last 12 months
0
Product codes
2
Most recent
2021-01-07
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
LNH System, Nuclear Magnetic Resonance Imaging Class II Radiology 2 2020-08-11
LLZ System, Image Processing, Radiological Class II Radiology 1 2021-01-07
Filings

All 510(k) clearances (3)

Date K-number Device Code Class Specialty
2021-01-07 K202414 BrainInsight LLZ Class II Radiology
2020-08-11 K201722 Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System LNH Class II Radiology
2020-02-06 K192002 Lucy Point-of-Care Magnetic Resonance Imaging Device LNH Class II Radiology
Data source: openFDA · Generated 2026-09-07 09:19 · Last ingest 2026-09-07T13:19:27.426703 · Pipeline: Chrysalis Intelligence