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 2026-09-09FDA-cleared profile
Arterys MICA
Arterys Inc.
Authorized purpose: Support-tool image processing for quantitative cardiovascular assessment and oncologic lesion evaluation, quantification, follow-up, and documentation to aid trained healthcare professionals in diagnosis; the software does not directly generate a diagnosis or potential findings.
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.
Product overview
Start with the essentials
Authorized purpose: Support-tool image processing for quantitative cardiovascular assessment and oncologic lesion evaluation, quantification, follow-up, and documentation to aid trained healthcare professionals in diagnosis; the software does not directly generate a diagnosis or potential findings.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Support-tool image processing for quantitative cardiovascular assessment and oncologic lesion evaluation, quantification, follow-up, and documentation to aid trained healthcare professionals in diagnosis; the software does not directly generate a diagnosis or potential findings.
- Which images or clinical context are in scope? Modality: CT/CTA; MRI Anatomy or clinical context: Heart and major vessels for Cardio AI; oncology lesion anatomy is not further specified in the FDA statement. Input: Pre-existing DICOM or non-DICOM medical data, including CT or MR images uploaded from a PACS or scanner; Cardio AI supports 1.5T and 3.0T cardiovascular MR images, and Oncology AI processes MR or CT images.
- Who uses it? Intended users: Trained healthcare professionals.
- What does the software produce? Output: Stored, processed, and transferred images and patient information; filtered and digitally manipulated images; quantitative cardiovascular data for blood flow and ventricular function; and oncology lesion presence, evaluation, quantification, follow-up, and documentation support.
- What is its most important limitation? Key limitation: Arterys MICA provides image and related information for interpretation by a trained professional and does not directly generate a diagnosis or potential findings. Cardio AI validation is stated for 1.5T and 3.0T MR scanners; the client requires monitors meeting appropriate technical specifications for image diagnosis.
Clinical takeaway
Clinical role: Support-tool image processing for quantitative cardiovascular assessment and oncologic lesion evaluation, quantification, follow-up, and documentation to aid trained healthcare professionals in diagnosis; the software does not directly generate a diagnosis or potential findings.
Evidence takeaway
Evidence from the reviewed source record: Safety and performance were evaluated through software verification and validation against IEC 62304, ISO 14971, and FDA software and cybersecurity guidance. The packet reports hundreds of verification and validation tests, including mammography display-quality testing and comparison to Medis MR-CT VVA, but provides no numeric sensitivity, specificity, AUC, Dice, correlation, or reader-delta endpoint.
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
- Support-tool image processing for quantitative cardiovascular assessment and oncologic lesion evaluation, quantification, follow-up, and documentation to aid trained healthcare professionals in diagnosis; the software does not directly generate a diagnosis or potential findings.
- Intended users
- Trained healthcare professionals.
- Care setting and population
- Diagnostic and therapy follow-up examinations.
- Workflow role
- Image viewing, storage, transfer, filtering, digital manipulation, quantitative measurement, cardiovascular flow and ventricular-function analysis, and oncology lesion follow-up and documentation.
- Required input
- Pre-existing DICOM or non-DICOM medical data, including CT or MR images uploaded from a PACS or scanner; Cardio AI supports 1.5T and 3.0T cardiovascular MR images, and Oncology AI processes MR or CT images.
- Output and human action
- Stored, processed, and transferred images and patient information; filtered and digitally manipulated images; quantitative cardiovascular data for blood flow and ventricular function; and oncology lesion presence, evaluation, quantification, follow-up, and documentation support.
- Limitations
- Arterys MICA provides image and related information for interpretation by a trained professional and does not directly generate a diagnosis or potential findings. Cardio AI validation is stated for 1.5T and 3.0T MR scanners; the client requires monitors meeting appropriate technical specifications for image diagnosis.
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.
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- The system has a Chrome desktop-browser client and Linux server, receives pre-existing images from a PACS or scanner, and manages DICOM and non-DICOM data, images, and patient information. The packet does not establish a specific local PACS, RIS, EHR, or interface version.
- Deployment and data flow
- On-cloud
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
Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Training and support
- Vendor documentation pending
Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Monitoring and change control
- Vendor documentation pending
Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
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
- Safety and performance were evaluated through software verification and validation against IEC 62304, ISO 14971, and FDA software and cybersecurity guidance. The packet reports hundreds of verification and validation tests, including mammography display-quality testing and comparison to Medis MR-CT VVA, but provides no numeric sensitivity, specificity, AUC, Dice, correlation, or reader-delta endpoint.
- Reported sensitivity
- Research pending
This field has not been curated yet.
- Reported specificity
- Research pending
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
No public price or quote for the exact K192437 configuration was established in this review.
- Reimbursement and coding
- Not established in reviewed sources
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 K192437. 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.
Buyer worksheet
Open questions to take to the vendor
- Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Verify pricing and total cost: No public price or quote for the exact K192437 configuration was established in this review.
- Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
- Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Exact FDA record reviewedStatus
2026-09-20Last searched
19Fields reviewed
9Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.
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
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FDA K192437: Arterys MICA
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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Arterys MICA model card (K192437)
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PubMed biomedical literature index
Scope: evidenceDiscovery
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ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
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openFDA exact recall query for K192437
Scope: postmarketSafety
Research history
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K192437 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
fda record reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
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