Workflow Box

K181572

Mirada Medical Ltd. · cleared 2018-07-10 · product code QKB · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“Workflow Box is a software application that enables the routing of image data and structures to automatic image processing workflows, including atlas based contouring, image registration based re-contouring and machine learning based contouring.”

Algorithmdeformable image registration and machine learning based algorithms

source quote (p.5)

“Workflow Box includes processing components for automatically contouring imaging data using deformable image registration and machine learning based algorithms.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Standalone

sample size not stated

endpoints: meeting user needs; meeting device requirements; demonstrating substantial equivalence

standards: CFR 21 Part 820, DICOM standard

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

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

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).