SwiftMR

K210999

AIRS Medical Inc. · cleared 2021-10-14 · product code LLZ · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“SwiftMR, is software used as a Medical Device (SaMD) consisting of a software algorithm that enhances images taken by MRI scanners.”
Algorithmdeep learning algorithm, convolutional neural network-based filtering
source quote (p.4)
“The deep learning algorithm produces enhanced images as outputs with reduced noise and increased sharpness in DICOM format. The device applies both denoising and sharpness increase functions simultaneously. SwiftMR implements an image enhancement algorithm using convolutional neural network-based filtering.”
Adaptive (vs locked)No
source quote (p.4)
“There are two deep learning algorithms that should be selected by users according to the pulse sequences. One is for the general pulse sequences and the other is for the TOF pulse sequences. The two deep learning algorithms share the same network architecture, input data generation method, training procedures. The only difference between the two deep learning algorithms is the input / label dataset used for training.”
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Retrospective clinical

sample size not stated

endpoints: average signal-to-noise ratio (SNR) of the SwiftMR-processed image series is increased by 40% or more compared to the value of the original image series; the FWHM of a selected region of interest (ROI) is decreased by 0.13% or more after applying SwiftMR for at least 90% of the test datasets

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

48
recalls in product code, 24mo
295
MAUDE reports in code, 12mo
+683%
vs code's own 3-yr baseline
29
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K253775 (decision 2026-03-26) from Airs Medical, Inc. for a matching device line ("SwiftMR") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K253775

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K230854 (decision 2023-10-27) from AIRS Medical Inc. for a matching device line ("SwiftMR") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K230854

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K220416 (decision 2022-05-25) from AIRS Medical Inc. for a matching device line ("SwiftMR") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K220416

  • adverse_event_inflection

    MAUDE adverse-event reports for product code LLZ: 295 in the 12 months ending 2026-06, vs a 37.7/12mo average over the prior 3 windows (+683%). Code-level count — reports are not attributed to this specific device.

    first seen 2026-07-08 · openFDA /device/event.json count=date_received product_code=LLZ

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (GE Medical Systems SCS, initiated 2026-05-08): "GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:99042

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands, initiated 2026-03-05): "Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98520

  • …and 23 more.

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/K210999