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 using convolutional neural network-based filtering

source quote (p.6)

“SwiftMR implements an image enhancement algorithm using convolutional neural network-based filtering.”

Adaptive (vs locked)FDA source did not state this

PCCPNo

Cybersecurity addressedNo

Validation studies (2)

Bench

sample size not stated

Retrospective clinical

sample size not stated

endpoints: the 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

recalls in product code, 24mo

295

MAUDE reports in code, 12mo

+683%

vs code's own 3-yr baseline

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). 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).