DeviceClearance

Product code QXZ— Cardiovascular

Cleerly ISCHEMIA

Classification name
Adjunctive Epicardial Vascular Physiologic Status Indicator
Device class
Class 2
Regulation
21 CFR 870.2200
Advisory panel
Cardiovascular
Total cleared
1
First cleared
Most recent

FDA classification definition

“The adjunctive epicardial vascular physiologic status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting the possible presence of functionally significant coronary artery disease to suggest the need for further testing. This device is intended for adjunctive use with other clinical workup or patient information and is not intended to quantify the degree to which epicardial disease is limiting flow through a vessel nor is it intended to independently direct therapy.”

— U.S. Food and Drug Administration, device classification record for product code QXZ under 21 CFR 870.2200, via openFDA

Market context for product code QXZ

FDA has cleared 1 device under product code QXZ, all in 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QXZ

Recent clearances under product code QXZ

Data sourced from openFDA. This site is unofficial and independent of the FDA.