Swoop Portable MR Imaging System

K221923

Hyperfine, Inc. · cleared 2022-07-28 · product code LNH · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.4)

“The Swoop® system is a portable MRI device that allows for patient bedside imaging. The system enables visualization of the internal structures of the head using standard magnetic resonance imaging contrasts. The main interface is a commercial off-the-shelf device that is used for operating the system, providing access to patient data, exam setup, exam execution, viewing MRI image data for quality control purposes, and cloud storage interactions. The system can generate MRI data sets with a broad range of contrasts. The user interface includes touch screen menus, controls, indicators, and navigation icons that allow the operator to control the system and to view imagery. The Swoop® 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.”

Algorithmimage reconstruction algorithm utilizes deep learning

source quote (p.4)

“The Swoop® 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.7)

“Testing to verify cybersecurity controls and management.”

Validation studies (7)

Bench

sample size not stated

endpoints: 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: electrical safety and EMC meet the criteria

standards: ANSI/AAMI ES 60601-1:2005/(R)2012, IEC 60601-1-2:2014, IEC 60601-2-33:2015, NEMA MS 8-2016

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: Testing to verify cybersecurity controls and management

standards: FDA guidance, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices"

Bench

sample size not stated

endpoints: Verification testing to ensure the design outputs meet the design input requirements

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: Validation studies to ensure the device meets user needs and performs as intended

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

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
re_clearance
The FDA AI/ML device list shows a newer 510(k) K230208 (decision 2023-02-22) 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:K230208
…and 3 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).