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: 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.
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: 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.
Overview status: Source-reviewed overview
- What does this software do? Authorized 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.
- Which images or clinical context are in scope? Modality: CT/CTA; MRI Anatomy or clinical context: 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. 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.
- Who uses it? Intended users: Trained healthcare professionals.
- What does the software produce? Output: 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.
- What is its most important limitation? Key limitation: 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.
Clinical takeaway
Clinical role: 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.
Evidence takeaway
Evidence from the reviewed source record: 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.
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.
- Intended users
- Trained healthcare professionals.
- Care setting and population
- Diagnostic and therapy-follow-up imaging workflows; the FDA packet does not specify a facility type.
- Workflow role
- Image management/viewing and post-processing support for cardiac and oncology workflows, with clinician interpretation and responsibility.
- 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.
- 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.
- 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.
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
- Modality
- CT/CTA; MRI
- 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.
- Clearance type
- 510(k)
- Decision date
- 2018-10-17
- FDA status
- FDA-cleared
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.
- 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
- 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.
- 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 K182034 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 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.
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 K182034 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
18Fields 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
-
FDA K182034: Arterys MICA
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
-
Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
Arterys MICA model card (K182034)
-
PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K182034
Scope: postmarketSafety
Research history
-
K182034 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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