Swoop® Portable MR Imaging System®
K232760Hyperfine, Inc. · cleared 2023-10-06 · product code LNH · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“The Swoop 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, and FLAIR sequences, specifically in terms of reductions in image noise and blurring.”
source quote (p.5)
“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.”
source quote (p.8)
“Testing to verify cybersecurity controls and management.”
Validation studies (1)
Bench
sample size not stated
endpoints: Software verification testing in accordance with the design requirements to ensure that the software requirements were met.; Testing to verify the subject device meets all image quality criteria.; Validation to ensure the subject device meets user needs and performs as intended.; Biocompatibility testing of patient-contacting materials.; Cleaning and disinfection validation of patient-contacting materials.; Electrical Safety, EMC, and Essential Performance testing.; Characterization of the Specific Absorption Rate for Magnetic Resonance Imaging Systems.; Testing to verify cybersecurity controls and management.
standards: IEC 62304:2015, FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", 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, ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2010, FDA Guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling", ISO 17664:2017, ASTM F3208-17, ANSI/AAMI ES 60601-1:2005/(R)2012, IEC 60601-1-2:2014, IEC 60601-1-6:2013, NEMA MS 8-2016, FDA guidance, "Content of Premarket Submissions for Management of Cybersecurity 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
- 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
- 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).