Swoop® Portable MR Imaging® System
K253489Hyperfine, Inc. · cleared 2025-12-12 · product code LNH · Radiology
Premarket evidence — what FDA accepted
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.”
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.”
source quote (p.9)
“Testing to verify cybersecurity controls and management.”
Validation studies (3)
Standalone
n=8 patients · 6 site(s)
endpoints: Normalized mean squared error (NMSE); structural similarity index (SSIM)
standards: IEC 62304:2016, NEMA MS 1-2008 (R2020), NEMA MS 3-2008 (R2020), NEMA MS 9-2008 (R2020), NEMA MS 12-2016, ANSI/AAMI ES 60601-1:2005/(R)2012, IEC 60601-1-2:2014, IEC 60601-1-6:2013, ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2010, ISO 17664:2017, ASTM F3208-17, NEMA MS 8-2016
Standalone
n=12 patients · 5 site(s)
endpoints: Contrast-to-Noise Ratio (CNR)
Reader study (MRMC)
n=34 patients · 8 site(s)
endpoints: image quality and the consistency of diagnosis using both methods in the categories of noise, sharpness, contrast, geometric fidelity, artifact, and overall image quality
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
- 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).