Swoop® Portable MR Imaging® System

K240944

Hyperfine, Inc. · cleared 2024-07-16 · product code LNH · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.4)

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

AlgorithmThe image reconstruction algorithm utilizes deep learning to provide improved image quality for T1W, T2W, FLAIR, and DWI sequences. It includes Noise correction and line noise suppression, Advanced Gridding for T1W, T2W, and FLAIR, Fast Iterative Shrinkage Thresholding Algorithm (FISTA) for DWI, and Image Post-Processing features such as Advanced Denoising, Image orientation transform, Geometric distortion correction, Receive coil intensity correction, and DICOM output.

source quote (p.4)

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

Adaptive (vs locked)No

PCCPNo

Cybersecurity addressedYes

source quote (p.7)

“Testing to verify cybersecurity controls and management.”

Validation studies (8)

Bench

sample size not stated

endpoints: Software verification testing in accordance with the design requirements to ensure that the software requirements were met.

standards: IEC 62304:2015, FDA Guidance, "Content of Premarket Submissions for Device Software Functions"

Bench

sample size not stated

endpoints: Testing to verify the subject device meets all image quality criteria.

standards: NEMA MS 1-2008 (R2020), NEMA MS 3-2008 (R2020), NEMA MS 9-2008 (R2020), NEMA MS 12-2016, American College of Radiology (ACR) Phantom Test Guidance for Use of the Large MRI Phantom for the ACR MRI Accreditation Program, American College of Radiology standards for named sequences

Bench

sample size not stated

endpoints: Testing to verify cybersecurity controls and management.

standards: FDA Guidance, "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions"

Bench

sample size not stated

endpoints: Validation to ensure the subject device meets user needs and performs as intended.

standards: FDA Guidance, "Content of Premarket Submissions for Device Software Functions"

Bench

sample size not stated

endpoints: Biocompatibility testing of patient-contacting materials.

standards: ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2010

Bench

sample size not stated

endpoints: Cleaning and disinfection validation of patient-contacting materials.

standards: FDA Guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling", ISO 17664:2017, ASTM F3208-17

Bench

sample size not stated

endpoints: Electrical Safety, EMC, and Essential Performance testing.

standards: ANSI/AAMI ES 60601-1:2005/(R)2012, IEC 60601-1-2:2014, IEC 60601-1-6:2013

Bench

sample size not stated

endpoints: Characterization of the Specific Absorption Rate for Magnetic Resonance Imaging Systems.

standards: NEMA MS 8-2016

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
re_clearance
The FDA AI/ML device list shows a newer 510(k) K251276 (decision 2025-05-21) 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:K251276
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).