Radiology AI Directory

FDA-cleared profile

Arterys MICA

Arterys Inc.

DICOM/non-DICOM image and data management with optional quantitative cardiac MR and oncology lesion evaluation, quantification, follow-up, and documentation support; the software does not directly generate a diagnosis or potential findings.

Cardiac imagingOncology quantificationQuantification and segmentation
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

Clinical details

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose
DICOM/non-DICOM image and data management with optional quantitative cardiac MR and oncology lesion evaluation, quantification, follow-up, and documentation support; the software does not directly generate a diagnosis or potential findings.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Intended users
Trained healthcare professionals.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Care setting and population
Diagnostic and therapy-follow-up imaging workflows; the FDA packet does not specify a facility type.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Workflow role
Image management/viewing and post-processing support for cardiac and oncology workflows, with clinician interpretation and responsibility.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Required input
Pre-existing DICOM CT or MR images from a PACS or scanner plus non-DICOM medical data; Cardio uses multi-slice, multi-phase, and velocity-encoded cardiovascular MR; mammography is excluded.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Output and human action
Filtered and digitally manipulated images, quantitative measurements, cardiac quantitative data, and oncology lesion presence/absence assessment, evaluation, quantification, follow-up, and documentation; reports can be downloaded to PACS or a computer.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Limitations
The clinician retains ultimate responsibility for diagnosis and visual comparison; MICA is a complement to standard procedures and does not directly generate a diagnosis or potential findings; mammography is excluded from the stated data-management use.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

Regulatory identity

FDA record and catalog context

The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.

FDA submission
K182034
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA; MRI
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Anatomy
Heart and major vessels for the optional Cardio AI module; lung and liver lesions or nodules for the optional Oncology AI module; the base viewer handles broader radiological image data.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2018-10-17
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
Chrome desktop client with a Linux server; accepts DICOM/non-DICOM data from PACS or a scanner and supports DICOM-based reporting/output. The FDA packet does not establish a current cloud deployment or specific local interface versions.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Deployment and data flow
On-cloud
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for Arterys MICA; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission ยท checked 2026-09-09
Source

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.

Evidence summary
FDA performance section reports software verification and validation to specifications and applicable standards, including IEC 62304 and ISO 14971, with no numerical sensitivity, specificity, AUC, or clinical sample-size endpoint disclosed for this submission.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Reported sensitivity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

Reported specificity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

Costs and setup

Budget and ongoing governance

These are common procurement questions; unknown values remain visible until a source supports them.

Pricing and total cost
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

No public price or quote for the exact K182034 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-09

No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.

Safety and lifecycle

Postmarket record

Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.

Postmarket safety review
The exact-identifier FDA recall query returned no native recall record for K182034. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-09

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Exact FDA record reviewedStatus
2026-09-09Last searched
17Fields reviewed
9Source classes checked
0Awaiting review PubMed leads
0Awaiting review trial leads
0Unreviewed FDA recall leads

Exact-submission ACR model-card fields were normalized under the current provenance rules; vendor and independent-study confirmation remain distinct. Exact FDA scope controls clinical claims. ACR provides bounded exact-submission catalog context. Candidate literature metadata remains a discovery queue until full-text identity, endpoint, population, and version review is completed. Automated exact-name discovery found 0 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

Source classes: fda ai list, fda decision summary, acr ai central product, fda device recall, literature index, trial registry, pubmed, clinical trials, openfda device recall

Sources & history

How this profile was documented

Open the ledger for source dates, scope, and research-record updates.

View source ledger and history

Source ledger

  1. FDA K182034: Arterys MICA

    U.S. Food and Drug Administration - Published 2018-10-17 - Accessed 2026-09-09

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. Arterys MICA model card (K182034)

    American College of Radiology - Published 2026-06-26 - Accessed 2026-09-01

  4. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  5. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  6. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  7. openFDA exact recall query for K182034

    U.S. Food and Drug Administration - Accessed 2026-09-09

    Scope: postmarketSafety

Research history

  1. K182034 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

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