Swoop® Portable MR Imaging System

K230208

Hyperfine, Inc. · cleared 2023-02-22 · product code LNH · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.5)

“The Swoop system is a portable MRI device that allows for patient bedside imaging. System image reconstruction algorithm utilizes deep learning to provide improved image quality for T1W, T2W, and FLAIR sequences, specifically in terms of reductions in image noise and blurring.”

Algorithmdeep learning

source quote (p.5)

“System image reconstruction algorithm utilizes deep learning to provide improved image quality for T1W, T2W, and FLAIR sequences, specifically in terms of reductions in image noise and blurring.”

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 (7)

Bench

sample size not stated

endpoints: Software requirements were met

standards: IEC 62304:2006, FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"

Bench

sample size not stated

endpoints: Image quality criteria were met

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: Device meets user needs and performs as intended

standards: FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"

Bench

sample size not stated

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

Bench

sample size not stated

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

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

Bench

sample size not stated

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
re_clearance
The FDA AI/ML device list shows a newer 510(k) K240944 (decision 2024-07-16) 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:K240944
re_clearance
The FDA AI/ML device list shows a newer 510(k) K232760 (decision 2023-10-06) 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:K232760
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
…and 1 more.

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).