Swoop® Portable MR Imaging® System

K251276

Hyperfine, Inc. · cleared 2025-05-21 · product code LNH · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.4)

“The Swoop Portable MR Imaging System is a portable, ultra-low field magnetic resonance imaging device for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. The Swoop System image reconstruction algorithm utilizes deep learning to provide improved image quality for T1W, T2W, FLAIR, and DWI sequences.”

Algorithmdeep learning

source quote (p.6)

“The Swoop System image reconstruction algorithm utilizes deep learning to provide improved image quality for T1W, T2W, FLAIR, and DWI sequences.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.8)

“Testing to verify cybersecurity controls and management.”

Validation studies (3)

Retrospective clinical

n=118 patients

endpoints: Normalized mean squared error (NMSE); structural similarity index (SSIM)

Retrospective clinical

n=43 patients · 8 site(s)

endpoints: Contrast-to-Noise Ratio (CNR)

Reader study (MRMC)

n=46 patients · 11 site(s)

endpoints: image quality (noise, sharpness, contrast, geometric fidelity, artifact, overall image quality); consistency of diagnosis

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

100

recalls in product code, 24mo

510

MAUDE reports in code, 12mo

+5%

vs code's own 3-yr baseline

drift signals on this device

re_clearance
The FDA AI/ML device list shows a newer 510(k) K253489 (decision 2025-12-12) from Hyperfine, Inc. for a matching device line ("Swoop® Portable MR Imaging® System") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K253489
re_clearance
The FDA AI/ML device list shows a newer 510(k) K250236 (decision 2025-05-30) from Hyperfine, Inc. for a matching device line ("Swoop® Portable MR Imaging® System (V2)") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K250236
recall_reason_pattern
Software/algorithm-related recall in product code LNH (Philips North America, initiated 2026-04-14): "The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction " Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98779
recall_reason_pattern
Software/algorithm-related recall in product code LNH (Philips North America, initiated 2025-12-03): "The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS)." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98111

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).