FDA.reportPublic FDA data

CLEERLY, INC

Matched from indexed company URL: Cleerly, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30171672913017167291CLEERLY, INC1N2026-01-011099 18th Street Suite 2860 Denver CO US 80202

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860001924114Cleerly Labs - 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.646-362-4255info@cleerlyhealth.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2753072010520277K242338Cleerly LABS (v2.0)QIH2025-03-07
2753071980963780K231335Cleerly ISCHEMIAQXZ2023-09-08
2753071021230614K202280Cleerly Labs v2.0LLZ2020-10-02

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QIH12025-03-07
QXZ12023-09-08
LLZ12020-10-02

PMN#

GUDID#

Cleerly Labs - 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.

2022-02-08