Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
K212456Hyperfine, Inc. · cleared 2021-11-17 · product code LNH · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“The Swoop™ Point-of-Care MRI 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. ... This subject device in this submission includes a change to the image reconstruction algorithm of the Swoop POC MRI device for the T1W, T2W, and FLAIR sequences. The image reconstruction change utilizes deep learning to provide improved image quality, specifically in terms of reductions in image noise and blurring.”
source quote (p.5)
“This subject device in this submission includes a change to the image reconstruction algorithm of the Swoop POC MRI device for the T1W, T2W, and FLAIR sequences. The image reconstruction change utilizes deep learning to provide improved image quality, specifically in terms of reductions in image noise and blurring. This change replaces the non-uniform FFT-gridding operation in the reconstruction pipeline with Advanced Gridding and adds an Advanced Denoising step in the image postprocessing stage.”
source quote (p.8)
“Testing to verify cybersecurity controls and management.”
Validation studies (6)
Bench
sample size not stated
endpoints: Testing to verify advanced reconstruction models do not alter image features or introduce artifacts.; Testing to verify the ability for the expert-mode users to toggle between linear reconstruction and advanced reconstruction.; Testing to verify that image quality with advanced reconstruction is acceptable,; Testing to verify basic software functionality is unchanged from releases.; Analysis of the verification completed to assess robustness, stability, and generalizability of the advanced reconstruction models.; Testing to verify image performance with advanced reconstruction meets all image quality criteria.; Validation studies to confirm that the device meets user needs and performs as intended.
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
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: Testing to verify cybersecurity controls and management.
standards: Cybersecurity as recommended in FDA guidance, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices"
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
- 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).