1 device · 1 company · 2023
Product code QXZ: Adjunctive Epicardial Vascular Physiologic Status Indicator
1 device under product code QXZ, 2023, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Adjunctive Epicardial Vascular Physiologic Status Indicator. 21 CFR 870.2200, Class II. 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. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Cleerly ISCHEMIAK231335 · 510(k) | Cleerly, Inc | Cardiovascular | database entry |
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