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. It provides the capability to store images and patient information, and perform filtering, digital manipulation, and quantitative measurements. The client software is designed to run on standard personal and business computers and on monitors/screens that meet appropriate technical specifications for image diagnosis. Arterys MICA includes an optional Cardio Al 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. It provides clinically relevant and reproducible, quantitative data, and has been tested and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners. Arterys MICA includes an optional 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. It is a tool used to support 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.”
AlgorithmThe device includes an optional Cardio AI module to analyze the heart and its major vessels using multi-slice, multi-phase, and velocity-encoded cardiovascular MR images to quantify blood flow and ventricular function. It also includes an optional Oncology AI module to provide analytical tools to help users assess and document changes in morphological activity at diagnostic and therapy follow-up examinations, supporting the oncological workflow by confirming the absence or presence of lesions, including evaluation, quantification, follow-up, and documentation.
source quote (p.3)
“Arterys MICA includes an optional Cardio Al 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. It provides clinically relevant and reproducible, quantitative data, and has been tested and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners. Arterys MICA includes an optional 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. It is a tool used to support 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.”
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 (2)

Bench

sample size not stated

endpoints: software specifications; applicable performance standards

standards: IEC 62304:2006/AC:2015- Medical device software – Software life cycle processes, ISO 14971:2007 Medical devices -- Application of risk management to medical devices

Bench

sample size not stated

endpoints: performance test comparison to Medis MR-CT VVA

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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
1
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); 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/K192437