CLEERLY, INC.

Address:110 16th Street,Denver,CO,80202,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Image Processing, Radiological (LLZ) (1)

Premarket Exempt

Clear

Cleerly Labs - 00860001924114 Catalog Number :

Device Description : Cleerly Labs is used by trained medical professionals as an interactive tool for Cleerly Labs is used by trained medical professionals as an interactive tool for viewing and analyzing cardiac computed tomography (CT) data for determining the presence and extent of coronary plaques (i.e., atherosclerosis) and stenosis in patients who underwent Coronary Computed Tomography Angiography (CCTA) for evaluation of CAD or suspected CAD. This software post processes CT images obtained using any Computed Tomography (CT) scanner. The software provides tools for the measurement and visualization of coronary arteries.

Device Class : 2

Duns Number: 080706421

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

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