Chrysalis Intelligence · Sponsors · Hyperfine, Inc.

Hyperfine, Inc.

Guilforf, CT, US · 13 510(k) clearances

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Total clearances
13
2021-07-07 → 2025-12-12
Last 12 months
1
Product codes
2
Most recent
2025-12-12
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
LNH — — — 11 2025-12-12
QIH Automated Radiological Image Processing Software Class II Radiology 2 2022-12-16
Filings

All 510(k) clearances (13)

Date K-number Device Code Class Specialty
2025-12-12 K253489 Swoop® Portable MR Imaging® System LNH — —
2025-05-30 K250236 Swoop® Portable MR Imaging® System (V2) LNH — —
2025-05-21 K251276 Swoop® Portable MR Imaging® System LNH — —
2024-07-16 K240944 Swoop® Portable MR Imaging® System LNH — —
2023-10-06 K232760 Swoop® Portable MR Imaging System® LNH — —
2023-02-22 K230208 Swoop® Portable MR Imaging System™ LNH — —
2022-12-16 K223268 BrainInsight QIH Class II Radiology
2022-12-06 K223247 Swoop Portable MR Imaging System LNH — —
2022-07-28 K221923 Swoop Portable MR Imaging System LNH — —
2022-07-19 K220815 BrainInsight QIH Class II Radiology
2022-06-10 K221393 Swoop Portable MR Imaging System LNH — —
2021-11-17 K212456 Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System LNH — —
2021-07-07 K211818 Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System LNH — —
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence