Swoop® Portable MR Imaging® System (V2)
K250236Hyperfine, Inc. · cleared 2025-05-30 · product code LNH · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“The Swoop System (V2) is portable, ultra-low field MRI device that enables visualization of the internal structures of the head using standard magnetic resonance imaging contrasts. The Swoop System (V2) image reconstruction algorithm utilizes deep learning for optimized image quality.”
source quote (p.6)
“The Swoop System (V2) image reconstruction algorithm utilizes deep learning for optimized image quality.”
source quote (p.8)
“FDA Guidance, "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions"”
Validation studies (3)
Retrospective clinical
n=58 patients · 4 site(s)
endpoints: Normalized mean squared error (NMSE) and structural similarity index (SSIM) were used to compare the ability of Advanced Reconstruction to reproduce the ground truth image compared to Linear Reconstruction.
Retrospective clinical
n=15 patients · 2 site(s)
endpoints: The contrast-to-noise of hyper- and hypo- intense pathologies were measured with respect to healthy white matter tissue from the same image.; The mean CNR of Advanced Reconstruction was required to be greater than the mean CNR of the baseline Linear Reconstruction at statistical significance level of 0.05 for each sequence type.
Reader study (MRMC)
n=32 patients · 3 site(s)
endpoints: The reviewers rated the images using a five-point scale for image quality and the consistency of diagnosis using both methods in the categories of noise, sharpness, contrast, geometric fidelity, artifact, and overall image quality.; Advanced Reconstruction was required to perform at least as well as Linear Reconstruction in all categories (median score "0 on Likert scale) and perform better ("1 on Likert scale) in at least one of the quality-based categories.
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
- 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
- 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).