Arterys MICA

K182034

Arterys Inc. · cleared 2018-10-17 · product code LLZ · Radiology

FDA 510(k) summary for Arterys MICA (K182034)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
1
Cited predicates
3
Performance observations
0
Product code
LLZ
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“Arterys MICA is a dedicated software application used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system.”
AlgorithmCardio AI module for analyzing the heart and its major vessels using multi-slice, multi-phase, and velocity-encoded cardiovascular magnetic resonance (MR) images; Oncology AI module for analytical tools to help the user assess and document changes in morphological activity at diagnostic and therapy follow-up examinations.
source quote (p.5)
“Arterys MICA includes an optional Cardio 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. 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.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.8)
“Additionally, the software verification and validation activities were performed in accordance with ... the 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 (1)

Bench

sample size not stated

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

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

25
recalls in product code, 24mo
397
MAUDE reports in code, 12mo
+963%
vs code's own 3-yr baseline
33
drift signals on this device
  • predicate_cohort_contagion

    K182034 shares predicate K173542 with K192969 (Ezra Plexo Software), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-09-02 · predicate:K173542 sibling:K192969

  • 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

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K192437 (decision 2020-03-25) 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:K192437

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (Merge Healthcare, Inc., initiated 2026-07-22): "Software issue may cause measurements to be displayed inaccurately." Recalling firm is another firm in the same product code.

    first seen 2026-09-02 · recall res_event_number:99520

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (FUJIFILM Healthcare Americas Corporation, initiated 2026-07-22): "Software issue may cause the ruler measurement to be inaccurate." Recalling firm is another firm in the same product code.

    first seen 2026-09-02 · recall res_event_number:99529

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (Merge Healthcare, Inc., initiated 2026-06-30): "Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient st" Recalling firm is another firm in the same product code.

    first seen 2026-09-02 · recall res_event_number:99391

  • …and 27 more.

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 2026-09-02.

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.

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Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K182034