Cleerly Ischemia

GUDID 00860001924121

Cleerly ISCHEMIA is an add-on software module to Cleerly Labs (K202280, K190868) that determines the likely presence or absence of coronal vessel ischemia.

CLEERLY, INC.

Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software
Primary Device ID00860001924121
NIH Device Record Key234ab511-1754-49a3-992b-c3f87d354576
Commercial Distribution StatusIn Commercial Distribution
Brand NameCleerly Ischemia
Version Model Numberv1.0
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 Batchfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100860001924121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QXZAdjunctive Epicardial Vascular Physiologic Status Indicator

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-06
Device Publish Date2023-11-28

Devices Manufactured by CLEERLY, INC.

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