Cleerly Labs

GUDID 00860001924114

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.

CLEERLY, INC.

Radiology PACS software
Primary Device ID00860001924114
NIH Device Record Keyef46fe6e-9f2b-4a69-ae75-214172b1a551
Commercial Distribution StatusIn Commercial Distribution
Brand NameCleerly Labs
Version Model Numberv2.0
Company DUNS080706421
Company NameCLEERLY, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com
Phone646-362-4255
Emailinfo@cleerlyhealth.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860001924114 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-16
Device Publish Date2022-02-08

Devices Manufactured by CLEERLY, INC.

00860001924121 - Cleerly Ischemia2023-12-06 Cleerly ISCHEMIA is an add-on software module to Cleerly Labs (K202280, K190868) that determines the likely presence or absence
00860001924114 - Cleerly Labs2022-02-16Cleerly 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.
00860001924114 - Cleerly Labs2022-02-16 Cleerly Labs is used by trained medical professionals as an interactive tool for viewing and analyzing cardiac computed tomograp
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