QXZ · Class II · 21 CFR 870.2200

FDA Product Code QXZ: Adjunctive Epicardial Vascular Physiologic Status Indicator

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.

Leading manufacturers include Cleerly, Inc..

1
Total
1
Cleared
123d
Avg days
2023
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Adjunctive Epicardial Vascular Physiologic Status Indicator Devices (Product Code QXZ)

1 devices
1–1 of 1
Cleared Sep 08, 2023
Cleerly ISCHEMIA
K231335
Cleerly, Inc.
Cardiovascular · 123d

About Product Code QXZ - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QXZ since 2023, with 1 receiving FDA clearance (average review time: 123 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QXZ devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →