Arterys MICA

K192437

Arterys Inc. · cleared 2020-03-25 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.3)

“Arterys MICA software is a medical diagnostic application that displays, processes, stores, and transfers DICOM and non-DICOM medical data.”

AlgorithmCardio AI module which is used to analyze the heart and its major vessels using multi-slice, multi-phase, and velocity-encoded cardiovascular magnetic resonance (MR) images. Oncology AI module which provides analytical tools to help the user assess and document changes in morphological activity at diagnostic and therapy follow-up examinations.

source quote (p.5)

“Cardiac Workflow Module: evaluates multi-slice and multi-phase velocity-encoded cardiovascular MR images to quantify blood flow and ventricular function. Oncology Workflow Module: supports the oncological workflow by helping the user confirm the absence or presence of lesions including evaluation, quantification, follow-up and documentation of any such lesions within MR or CT images.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.7)

“Contained in Medical Devices and Content of Premarket Submission for Management of Cybersecurity in Medical Devices.”

Validation studies (1)

Bench

sample size not stated

standards: IEC 62304:2006/AC:2015, ISO 14971:2007

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

re_clearance
The FDA AI/ML device list shows a newer 510(k) K203744 (decision 2022-03-14) from Arterys Inc. for a matching device line ("Arterys MICA") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K203744

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).