Cleared Special

Swoop Portable MR Imaging System (K223247) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K223247 · Hyperfine, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2022
Decision
46d
Days
Class 2
Risk

K223247 is an FDA 510(k) clearance for the Swoop Portable MR Imaging System. 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 December 6, 2022 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Hyperfine, Inc. devices

Submission Details

510(k) Number K223247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2022
Decision Date December 06, 2022
Days to Decision 46 days
Submission Type Special
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
61d faster than avg
Panel avg: 107d · This submission: 46d
Pathway characteristics
Modification to existing cleared device.

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 K223247.
SIGNA Victor
K223439 · Ge Healthcare (Tianjin) Company Limited · Feb 2023
ECHELON Oval V6.2 MRI System
K221619 · Fujifilm Healthcare Corporation · Jan 2023
MR 5300 and MR 7700 R11 MR Systems
K223442 · Philips Medical Systems Nederlands B.V. · Dec 2022
Stage
K223079 · Spintech, Inc. · Oct 2022
uMR Omega with uWS-MR-MRS
K220332 · Shanghai United Imaging Healthcare Co., Ltd. · Oct 2022
Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
K222968 · Canon Medical Systems Corporation · Oct 2022