SwiftMR
K220416AIRS Medical Inc. · cleared 2022-05-25 · product code LLZ · Radiology
Premarket evidence — what FDA accepted
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.”
source quote (p.4)
“The deep learning algorithm produces enhanced images as outputs with reduced noise and increased sharpness in DICOM format. SwiftMR implements an image enhancement algorithm using convolutional neural network-based filtering. The deep learning algorithm using convolutional neural network-based filtering performs denoising function and newly added sharpness filter performs sharpening function in the subject device.”
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; FWHM of a selected region of interest (ROI) is decreased by by 0.43% (level 1), 1.7% (level 2), 2.3% (level 3), 3.6% (level 4), 4.5% (level 5) or more for at least 90% of the dataset
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
- 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
- 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
- recall_reason_pattern
Software/algorithm-related recall in product code LLZ (GE Medical Systems, LLC, initiated 2026-01-30): "There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, w" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98428
- …and 22 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).