SwiftSight-Brain

K251483

AIRS Medical Inc. · cleared 2025-09-23 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“SwiftSight-Brain is a fully automated MR image analysis software that provides automatic labeling, visualization, and volumetric quantification of brain structures from a set of MR images and returns segmented images and morphometric reports.”
AlgorithmAutomatic segmentation and quantification of brain structures using deep learning
source quote (p.7)
“Automatic segmentation and quantification of brain structures using deep learning”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (4)

Retrospective clinical

n=72 cases

endpoints: Dice's coefficient

Retrospective clinical

n=160 cases

endpoints: Dice's coefficient

Retrospective clinical

n=72 cases

endpoints: percentage absolute volume differences

Retrospective clinical

n=85 cases

endpoints: mean absolute lesion volume difference

Reported performance (3 observations)

diceas written: “Dice's coefficient (major subcortical brain structures)”0.8
source quote (p.8)
“For major subcortical brain structures Dice's coefficients were above 80%”
diceas written: “Dice's coefficient (major cortical brain structures)”0.75
source quote (p.8)
“and for major cortical were above 75%.”
diceas written: “Dice's coefficient (T2 weighted FLAIR lesion segmentation)”0.8
source quote (p.9)
“SwiftSight-Brain's lesion segmentation accuracy compared to expert manual segmentations of T2 weighted FLAIR scan was evaluated using Dice's coefficient metric, which exceeds 0.80.”

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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

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/K251483