SwiftMR

K210999

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

FDA 510(k) summary for SwiftMR (K210999)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
1
Cited predicates
1
Performance observations
0
Product code
LLZ
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

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

25
recalls in product code, 24mo
397
MAUDE reports in code, 12mo
+963%
vs code's own 3-yr baseline
34
drift signals on this device
  • predicate_cohort_contagion

    K210999 shares predicate K191688 with K202404 (BoneMRI), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-09-02 · predicate:K191688 sibling:K202404

  • 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

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (Merge Healthcare, Inc., initiated 2026-07-22): "Software issue may cause measurements to be displayed inaccurately." Recalling firm is another firm in the same product code.

    first seen 2026-09-02 · recall res_event_number:99520

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (FUJIFILM Healthcare Americas Corporation, initiated 2026-07-22): "Software issue may cause the ruler measurement to be inaccurate." Recalling firm is another firm in the same product code.

    first seen 2026-09-02 · recall res_event_number:99529

  • …and 28 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 2026-09-02.

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.

Related FDA clearances

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These are recent clearances in the same FDA product-code category. Shared classification does not by itself make a device an appropriate predicate.

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Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K210999