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FDA-cleared K242338

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.

Modality
CT/CTA
Anatomy
Heart/Coronary arteries
Decision
2025-03-07
FDA-cleared K202280

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.

Modality
CT/CTA
Anatomy
Heart; coronary arteries, plaques, and stenosis
Decision
2020-10-02
FDA-cleared K190868

Cleerly Labs

Cleerly Inc

Authorized purpose: Cleerly Labs provides interactive cardiac CT or CCTA analysis for the presence and extent of coronary plaque, atherosclerosis, and stenosis in coronary artery disease or suspected disease within the labeled workflow.

Modality
CT/CTA
Anatomy
Heart/Cardiovascular
Decision
2019-11-05