ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for Arterys Oncology DL; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission ยท checked 2026-09-09FDA-cleared profile
Arterys Oncology DL
Arterys Inc.
Authorized purpose: Oncology imaging workflow for viewing, manipulating, 3D visualizing, and comparing images and assessing/documenting morphological changes at diagnostic and therapy follow-up; supports lesion evaluation, quantification, follow-up, and documentation.
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: Oncology imaging workflow for viewing, manipulating, 3D visualizing, and comparing images and assessing/documenting morphological changes at diagnostic and therapy follow-up; supports lesion evaluation, quantification, follow-up, and documentation.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Oncology imaging workflow for viewing, manipulating, 3D visualizing, and comparing images and assessing/documenting morphological changes at diagnostic and therapy follow-up; supports lesion evaluation, quantification, follow-up, and documentation.
- Which images or clinical context are in scope? Modality: CT/CTA; MRI Anatomy or clinical context: Oncologic lesions, with semi-automated segmentation explicitly described for lung nodules and liver lesions. Input: DICOM medical images from CT or MR, potentially across multiple modalities and time points.
- Who uses it? Intended users: Clinicians or other healthcare professionals; the clinician retains responsibility for the pertinent diagnosis.
- What does the software produce? Output: MIP and volume-rendered views, manual and semi-automatic volumetric segmentation of lung nodules and liver lesions, co-registration, lesion-size quantification, longitudinal tracking, and Lung-RADS/LI-RADS reporting.
- What is its most important limitation? Key limitation: The clinician retains ultimate responsibility and must use standard practices and visual comparison of separate unregistered images; the software is a complement to those procedures.
Clinical takeaway
Clinical role: Oncology imaging workflow for viewing, manipulating, 3D visualizing, and comparing images and assessing/documenting morphological changes at diagnostic and therapy follow-up; supports lesion evaluation, quantification, follow-up, and documentation.
Evidence takeaway
Evidence from the reviewed source record: FDA performance evidence is non-clinical software verification, validation, and usability testing, including liver MR and lung MR deep-learning models and lung longitudinal tracking. No numerical clinical sensitivity, specificity, AUC, or clinical outcome study is disclosed.
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
- Oncology imaging workflow for viewing, manipulating, 3D visualizing, and comparing images and assessing/documenting morphological changes at diagnostic and therapy follow-up; supports lesion evaluation, quantification, follow-up, and documentation.
- Intended users
- Clinicians or other healthcare professionals; the clinician retains responsibility for the pertinent diagnosis.
- Care setting and population
- Diagnostic and therapy-follow-up oncology imaging workflow; the FDA packet does not specify a facility type.
- Workflow role
- Post-processing visualization, co-registration, longitudinal lesion tracking, measurement, and reporting support.
- Required input
- DICOM medical images from CT or MR, potentially across multiple modalities and time points.
- Output and human action
- MIP and volume-rendered views, manual and semi-automatic volumetric segmentation of lung nodules and liver lesions, co-registration, lesion-size quantification, longitudinal tracking, and Lung-RADS/LI-RADS reporting.
- Limitations
- The clinician retains ultimate responsibility and must use standard practices and visual comparison of separate unregistered images; the software is a complement to those procedures.
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
- DICOM-based multi-modality and multi-time-point image processing; the FDA packet does not establish a specific PACS, RIS, or EHR interface or a current deployment model.
- Deployment and data flow
- Vendor documentation pending
The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.
- 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 evidence is non-clinical software verification, validation, and usability testing, including liver MR and lung MR deep-learning models and lung longitudinal tracking. No numerical clinical sensitivity, specificity, AUC, or clinical outcome study is disclosed.
- 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 K173542 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 K173542. 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 deployment and data flow: The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.
- 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 K173542 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
17Fields 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 K173542: Arterys Oncology DL
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
-
Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
Arterys Oncology DL model card (K173542)
-
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 K173542
Scope: postmarketSafety
Research history
-
K173542 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
Alternatives
Related tools to compare
FDA-cleared K203744
Arterys MICA
Arterys Inc.
Manages, views, processes, stores, transfers, filters, manipulates, and quantitatively measures DICOM and non-DICOM images and data, with optional Cardio AI and Oncology AI...
- Modality
- CT/CTA; MRI
- Anatomy
- Multi-region
- Decision
- 2022-03-14
FDA-cleared K192437
Arterys MICA
Arterys Inc.
Support-tool image processing for quantitative cardiovascular assessment and oncologic lesion evaluation, quantification, follow-up, and documentation to aid trained healthcare...
- Modality
- CT/CTA; MRI
- Anatomy
- Heart and major vessels for Cardio AI; oncology lesion anatomy is not further specified in the FDA statement.
- Decision
- 2020-03-25
FDA-cleared K182034
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...
- 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.
- Decision
- 2018-10-17
FDA-cleared K242781
cvi42 Software Application
Circle Cardiovascular Imaging Inc.
View, post-process, and qualitatively and quantitatively evaluate cardiovascular MR and CT images in DICOM format to obtain diagnostic information as part of a comprehensive...
- Modality
- CT/CTA; MRI
- Anatomy
- Cardiovascular system; heart, coronary and adjacent vessels, and cardiac valves
- Decision
- 2024-10-15