Cleerly Ischemia

Primary DI: 00860001924121
Brand: Cleerly Ischemia
Company: CLEERLY, INC.
Model: v1.0
Device description: Cleerly ISCHEMIA is an add-on software module to Cleerly Labs (K202280, K190868) that determines the likely presence or absence of coronal vessel ischemia.
Published: 2023-11-28
Public version status: Update
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: true
OTC: false
Sterile: false
Single use: false

Contact Domains#

Code, Name table
Code	Name
QXZ	Adjunctive Epicardial Vascular Physiologic Status Indicator

Code, Device, Specialty table
Code	Device	Specialty	Class
QXZ	Adjunctive Epicardial Vascular Physiologic Status Indicator	Cardiovascular	2

Submission, Supplement table
Submission	Supplement
K231335	000

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K231335	000	Cleerly ISCHEMIA	Cleerly, Inc.	2023-09-08	QXZ

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
00860001924121	Primary	GS1	0

Source identifier, GTIN-14 normalized, UPC-A table
Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00860001924121	00860001924121	860001924121	0860001924121

Term, Definition table
Term	Definition
Radiological PACS-dedicated management software	A software program dedicated for installation on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of a broad range of radiological images throughout the healthcare system. As a PACS-dedicated software, it is not primarily intended for diagnosis support, triage, or treatment planning. It does not incorporate adaptive/dynamic machine learning (ML) models.

Phone, Email table
Phone	Email
646-362-4255	info@cleerlyhealth.com

Primary DI, Brand, Model table
Primary DI	Brand	Model	Catalog	Published
00860001924114	Cleerly Labs	v2.0		2022-02-08