Swoop® Portable MR Imaging® System (V2)— 510(k) K250236

Name: FDA 510(k) clearance K250236
Creator: U.S. Food and Drug Administration
Published: 2025-05-30

Substantially Equivalent

Hyperfine, Inc.

FDA 510(k) clearance K250236 for Swoop® Portable MR Imaging® System (V2), Substantially Equivalent on 2025-05-30. 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: 2025-01-27
Decision date: 2025-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guilforf, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LNH

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K262622 — Swoop® Portable MR Imaging® System2026-08-19
K254250 — MagicScan-1.5, GreenMR Serenity 1.5T2026-08-17
K253808 — AIR Recon DL2026-08-13
K260852 — MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise; MAGNETOM Flow.Pure2026-07-31
K261331 — I-Genius (100019400)2026-07-31

More clearances from Hyperfine, Inc.

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K253489 — Swoop® Portable MR Imaging® System2025-12-12
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
K230208 — Swoop® Portable MR Imaging System2023-02-22

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.