Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System

K212456

Hyperfine, Inc. · cleared 2021-11-17 · product code LNH · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
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.”
Algorithmdeep learning
source quote (p.5)
“The image reconstruction change utilizes deep learning to provide improved image quality, 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 (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 between 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: NESSUS scan test to verify any vulnerabilities and serve as a security baseline.; 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: 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: 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

100
recalls in product code, 24mo
510
MAUDE reports in code, 12mo
+5%
vs code's own 3-yr baseline
2
drift signals on this device
  • 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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K212456