Adjunctive Epicardial Vascular Physiologic Status Indicator
QXZ · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.2200
Classification
FDA Product Code
QXZ
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 870.2200
Review panel
CV
Medical specialty
Cardiovascular
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.