Arterys MICA
K203744Arterys Inc. · cleared 2022-03-14 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“Arterys MICA software is a medical diagnostic application that displays, processes, stores, and transfers DICOM and non-DICOM medical data.”
source quote (p.7)
“Arterys MICA uses many deep learning algorithms to reduce many tedious, time-consuming manual steps, such as segmentation, landmark identification, etc.”
source quote (p.7)
“The software does not perform any functions that could not be accomplished by a trained user with a manual method; the purpose of the automation is to save time and automate potential error-prone manual tasks, while allowing the results to be reviewed as per the normal clinical workflow.”
source quote (p.9)
“FDA Guidance documents Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and Content of Premarket Submission for Management of Cybersecurity in Medical Devices.”
Validation studies (3)
Bench
sample size not stated
standards: IEC 62304:2006/AC:2015- Medical device software – Software life cycle processes, ISO 14971:2019 Medical devices -- Application of risk management for medical devices, FDA Guidance documents Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Content of Premarket Submission for Management of Cybersecurity in Medical Devices
Bench
sample size not stated
Standalone
n=90 scans · 16 site(s)
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
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).