Radiology AI Directory

FDA-cleared profile

Cleerly Labs v2.0

Cleerly, Inc.

Authorized purpose: Web-based post-processing of cardiac CT data from CCTA performed for CAD or suspected CAD to view and analyze coronary plaques/atherosclerosis and stenosis and support measurement and visualization of coronary arteries.

Cardiac imagingDetection and CADeQuantification 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.

Product overview

Start with the essentials

Authorized purpose: Web-based post-processing of cardiac CT data from CCTA performed for CAD or suspected CAD to view and analyze coronary plaques/atherosclerosis and stenosis and support measurement and visualization of coronary arteries.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Web-based post-processing of cardiac CT data from CCTA performed for CAD or suspected CAD to view and analyze coronary plaques/atherosclerosis and stenosis and support measurement and visualization of coronary arteries.

Evidence takeaway

Evidence from the reviewed source record: K202280 reports no new clinical testing; non-clinical verification and validation supported the v2.0 intended use. Predicate-comparison results reproduced Pearson correlations of 0.91 lumen volume, 0.93 vessel volume, 0.85 total plaque volume, 0.94 calcified plaque volume, 0.74 non-calcified plaque volume, and 0.53 low-density non-calcified plaque volume, with Bland-Altman agreement of 96%, 97%, 95%, 95%, 95%, and 97%, respectively. These correlation and agreement endpoints are not sensitivity, specificity, or diagnostic accuracy.

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
Web-based post-processing of cardiac CT data from CCTA performed for CAD or suspected CAD to view and analyze coronary plaques/atherosclerosis and stenosis and support measurement and visualization of coronary arteries.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Intended users
Trained medical professionals appropriately trained in the software's functions, capabilities, and limitations.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Care setting and population
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

Confirm the intended care setting, patient population, and service line.

Workflow role
Interactive post-processing, visualization, semi-automatic segmentation, manual editing, measurement, and CORONARY report generation to support CAD evaluation; the report is not the final physician report.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Required input
DICOM 3.0-compliant or higher cardiac CT/CCTA images from any CT scanner.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Output and human action
2D/3D coronary visualization, editable lumen and vessel-wall segmentation, plaque/stenosis/vessel measurements, annotations for stents, CTOs, dominance, and anomalies, and an interactive CORONARY report that can send its text page to PACS.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Limitations
The software does not replace qualified medical judgment; users must account for interpolated data that may make tissue appear healthy, and outputs are based partly on user-editable segmentation and markers. No clinical testing was conducted for this v2.0 submission; the packet relies on non-clinical testing and previously reviewed predicate results.
  • 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
K202280
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Anatomy
Heart; coronary arteries, plaques, and stenosis
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2020-10-02
  • 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
Client-server Google Chrome application using DICOM 3.0 or higher and a secured network server; the packet describes sending the CORONARY report text page to PACS but does not establish specific PACS, RIS, EHR, hosting, or interface versions.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Deployment and data flow
On-premise
  • 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.

Supported acquisition environment

Scanner manufacturers: All

exact submission · checked 2026-09-01

Confirm currently supported software versions, protocols, and site-specific acquisition configurations.

Source

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for Cleerly Labs v2.0; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission · 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
K202280 reports no new clinical testing; non-clinical verification and validation supported the v2.0 intended use. Predicate-comparison results reproduced Pearson correlations of 0.91 lumen volume, 0.93 vessel volume, 0.85 total plaque volume, 0.94 calcified plaque volume, 0.74 non-calcified plaque volume, and 0.53 low-density non-calcified plaque volume, with Bland-Altman agreement of 96%, 97%, 95%, 95%, 95%, and 97%, respectively. These correlation and agreement endpoints are not sensitivity, specificity, or diagnostic accuracy.
  • 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.

Cleerly Labs V2.0 regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationPopulation described in the exact-submission ACR model card
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K202280
  • IndependenceIndependence not established

K202280

ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.

Source

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 K202280 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 K202280. 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
2026-09-20Last searched
23Fields reviewed
9Source classes checked
0Screened PubMed leads
1Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains 0 PubMed and 1 ClinicalTrials.gov candidate record. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was 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, 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 K202280: Cleerly Labs v2.0

    U.S. Food and Drug Administration - Published 2020-10-02 - 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. Cleerly Labs V2.0 model card (K202280)

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

    Scope: intendedUsers, output, limitations, evidenceSummary, anatomy, evidenceStudies, implementationCapabilities

  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 K202280

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

    Scope: postmarketSafety

Research history

  1. K202280 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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