Cleerly Ischemia

GUDID 00860001924121

Radiological PACS software

Primary Device ID	00860001924121
NIH Device Record Key	234ab511-1754-49a3-992b-c3f87d354576
Commercial Distribution Status	In Commercial Distribution
Brand Name	Cleerly Ischemia
Version Model Number	v1.0
Company DUNS	080706421
Company Name	CLEERLY, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00860001924121 [Primary]

QXZ	Adjunctive Epicardial Vascular Physiologic Status Indicator

Steralize Prior To Use	false
Device Is Sterile	false

00860001924121 - Cleerly Ischemia	2023-12-06Cleerly 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 Ischemia	2023-12-06 Cleerly ISCHEMIA is an add-on software module to Cleerly Labs (K202280, K190868) that determines the likely presence or absence
00860001924114 - Cleerly Labs	2022-02-16 Cleerly Labs is used by trained medical professionals as an interactive tool for viewing and analyzing cardiac computed tomograp