Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System— 510(k) K212456

Name: FDA 510(k) clearance K212456
Creator: U.S. Food and Drug Administration
Published: 2021-11-17

Substantially Equivalent

Hyperfine, Inc.

FDA 510(k) clearance K212456 for Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System, Substantially Equivalent on 2021-11-17. Applicant: Hyperfine, Inc.. Device class: 2.

Clearance details

Applicant: Hyperfine, Inc.
Product code: Code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2021-08-05
Decision date: 2021-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guildford, CT, US

Download summary PDF View on FDA.gov ↗

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K261331 — I-Genius (100019400)2026-07-31

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K253489 — Swoop® Portable MR Imaging® System2025-12-12
K250236 — Swoop® Portable MR Imaging® System (V2)2025-05-30
K251276 — Swoop® Portable MR Imaging® System2025-05-21
K240944 — Swoop® Portable MR Imaging® System2024-07-16
K232760 — Swoop® Portable MR Imaging System®2023-10-06

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.