Cleared Traditional

Swoop® Portable MR Imaging® System (V2) (K250236) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250236 · Hyperfine, Inc. · Radiology device
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May 2025
Decision
123d
Days
Class 2
Risk

K250236 is an FDA 510(k) clearance for the Swoop® Portable MR Imaging® System (V2). Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Hyperfine, Inc. (Guilforf, US). The FDA issued a Cleared decision on May 30, 2025 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hyperfine, Inc. devices

Submission Details

510(k) Number K250236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2025
Decision Date May 30, 2025
Days to Decision 123 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 107d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LNH System, Nuclear Magnetic Resonance Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LNH System, Nuclear Magnetic Resonance Imaging

All 485
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K250236.
MAGNETOM Avanto Fit
K250443 · Siemens Healthcare GmbH · Jun 2025
Sonic DL
K243667 · Ge Medical Systems, LLC · Jun 2025
Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System
K251397 · Philips Medical Systems Nederland B.V. · Jun 2025
uMR Omega
K243122 · Shanghai United Imaging Healthcare Co., Ltd. · May 2025
Swoop® Portable MR Imaging® System
K251276 · Hyperfine, Inc. · May 2025
SIGNA Prime Elite
K250379 · Ge Medical Systems, LLC · Mar 2025