Swoop Portable MR Imaging System
K221393Hyperfine, Inc. · cleared 2022-06-10 · product code LNH · Radiology
Premarket evidence — what FDA accepted
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.”
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.”
source quote (p.6)
“NESSUS scan test to verify any vulnerabilities and serve as a security baseline.”
Validation studies (1)
Bench
sample size not stated
endpoints: Testing to verify that the advanced reconstruction models do not alter image features or introduce artifacts.; Testing to verify that image quality with advanced reconstruction is acceptable.; Testing to verify basic software functionality is unchanged between releases.; NESSUS scan test to verify any vulnerabilities and serve as a security baseline.; Testing to verify image performance with advanced reconstruction meets all image quality criteria.; Validation studies to ensure the device meets user needs and performs as intended.; Testing to verify cybersecurity controls and management.; 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.
standards: IEC 62304:2006, 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, FDA guidance, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", 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
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
- 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 4 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).