Manual CCTA upload workflow
Current vendor instructions describe portal upload of zipped CCTA DICOM files and a generated Cleerly ID.
product family ยท checked 2026-09-05FDA-cleared profile
Cleerly LABS (v2.0)
Cleerly, Inc.
Authorized purpose: Assists trained professionals with coronary-vessel, lumen, vessel-wall, plaque and stenosis visualization and measurements from CCTA; it does not replace clinical judgment.
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: Assists trained professionals with coronary-vessel, lumen, vessel-wall, plaque and stenosis visualization and measurements from CCTA; it does not replace clinical judgment.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Assists trained professionals with coronary-vessel, lumen, vessel-wall, plaque and stenosis visualization and measurements from CCTA; it does not replace clinical judgment.
- Which images or clinical context are in scope? Modality: CT/CTA Anatomy or clinical context: Heart/Coronary arteries Input: DICOM 3.0-or-later cardiac CT/CCTA images from a CT scanner.
- Who uses it? Intended users: Trained healthcare professionals.
- What does the software produce? Output: Interactive CORONARY Report visualizations, segmented/labeled coronary anatomy and plaque/stenosis measurements; report pages may be sent to PACS but are not a final physician report.
- What is its most important limitation? Key limitation: Interpolation can appear healthy despite pathology at or below image resolution; users must review source images and use judgment.
Clinical takeaway
Clinical role: Assists trained professionals with coronary-vessel, lumen, vessel-wall, plaque and stenosis visualization and measurements from CCTA; it does not replace clinical judgment.
Evidence takeaway
Evidence from the reviewed source record: Software verification and production-release regression testing support the submission changes; no new clinical cohort was reported.
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
- Assists trained professionals with coronary-vessel, lumen, vessel-wall, plaque and stenosis visualization and measurements from CCTA; it does not replace clinical judgment.
- Intended users
- Trained healthcare professionals.
- Care setting and population
- Research pending
Confirm the intended care setting, patient population, and service line.
- Workflow role
- Measurement or quantification
Conservative normalization of explicit wording in an exact-submission source.
- Required input
- DICOM 3.0-or-later cardiac CT/CCTA images from a CT scanner.
- Output and human action
- Interactive CORONARY Report visualizations, segmented/labeled coronary anatomy and plaque/stenosis measurements; report pages may be sent to PACS but are not a final physician report.
- Limitations
- Interpolation can appear healthy despite pathology at or below image resolution; users must review source images and use judgment.
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
- Cleerly LABS is client-server software accessed through Chrome and integrates with a secured network server; current vendor instructions describe manual upload of zipped CCTA DICOM files to the customer portal.
Upload instructions are family-level workflow context, not a version-2.0 universal interface guarantee.
- Deployment and data flow
- Client-server architecture is described; hosting location and commercial deployment topology were not established.
- Security and privacy
- Vendor documentation pending
A secured-network description is not a scoped security attestation.
- Training and support
- Not established in reviewed sources
- Monitoring and change control
- Vendor documentation pending
Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
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
- Software verification and production-release regression testing support the submission changes; no new clinical cohort was reported.
- Reported sensitivity
- Not established in reviewed sources
- Reported specificity
- Not established in reviewed sources
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
Cleerly LABS v2.0 regulatory verification and regression testing
- DesignSoftware verification and production-release regression testing.
- PopulationNo clinical cohort reported.
- Scopeexact submission
- Tested versionCleerly LABS v2.0
- IndependenceIndependence not established
K242338
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
- Not established in reviewed sources
No public quote was located in reviewed material.
- Reimbursement and coding
- Research pending
No applicable payer policy was reviewed.
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
- Not established in reviewed sources
No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Buyer worksheet
Open questions to take to the vendor
- Verify care setting and population: Confirm the intended care setting, patient population, and service line.
- Verify security and privacy controls: A secured-network description is not a scoped security attestation.
- Verify training.
- Verify pricing and total cost: No public quote was located in reviewed material.
- Verify reimbursement and coding relevance: No applicable payer policy was reviewed.
- Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
- Verify recalls and postmarket safety signals: No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-06Last searched
22Fields reviewed
9Source classes checked
0Screened PubMed leads
1Screened trial leads
0Unreviewed FDA recall leads
Stored trial metadata is a randomized personalized plaque-management study sponsored by Cleerly; it does not identify Cleerly LABS v2.0 and was retained only as an unreviewed family lead, not promoted. The current discovery snapshot contains 0 PubMed and 1 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, vendor instructions for use, 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
-
K242338 FDA decision source
Scope: regulatoryIdentity, purpose, modality, anatomy
-
Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
Cleerly LABS (v2.0) model card (K242338)
Scope: intendedUsers, output, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
-
PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
Cleerly LABS v2.0: K242338 clearance and 510(k) summary
Scope: identity, clinical, implementation, evidence
-
Cleerly manual upload instructions
Scope: product_family_implementation
Research history
-
K242338 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
human reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
Alternatives
Related tools to compare
FDA-cleared K250288
TeraRecon Cardiovascular.Calcification.CT
Terarecon,Inc.
Automatic coronary-artery calcium plaque segmentation for downstream calcium scoring.
- Modality
- CT/CTA
- Anatomy
- Heart/Coronary Arteries
- Decision
- 2025-10-23
FDA-cleared K260497
DEEPVESSEL Plaque
Keya Medical Technology Co., Ltd.
Coronary plaque and stenosis quantification from CCTA
- Modality
- CT/CTA
- Anatomy
- Heart/Cardiovascular
- Decision
- 2026-06-04
FDA-cleared K252029
AI-CVD
HeartLung Corporation
AI-CVD provides automated quantitative CT-derived anatomical and density measurements for clinician review, including calcium scores, cardiac and vascular measurements, lung and...
- Modality
- CT/CTA
- Anatomy
- Chest, abdomen, heart, lungs, liver, aorta, pulmonary artery, bone, muscle, and fat
- Decision
- 2025-12-19
FDA-cleared K252217
CT VScore+
Canon Medical Informatics, Inc.
CT VScore+ evaluates calcified coronary lesions on ECG-gated, non-contrast cardiac CT in patients aged 30 years or older, automatically generating coronary calcium scores and...
- Modality
- CT/CTA
- Anatomy
- Heart/Cardiovascular
- Decision
- 2025-11-28