Cleared Traditional

K212456 - Swoop Point-of-Care Magnetic Resonance ...

K212456 is an FDA 510(k) clearance for Swoop Point-of-Care Magnetic Resonance ..., manufactured by Hyperfine, Inc.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K212456 · Hyperfine, Inc. · Radiology device
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Nov 2021
Decision
104d
Days
Class 2
Risk

K212456 is an FDA 510(k) clearance for the Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Hyperfine, Inc. (Guildford, US). The FDA issued a Cleared decision on November 17, 2021 after a review of 104 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

FDA 510(k) Submission Details - K212456

510(k) Number K212456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2021
Decision Date November 17, 2021
Days to Decision 104 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
3d faster than avg
Panel avg: 107d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LNH Device Classification - Class 2, Special Controls

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.

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All 840
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