Cleared Traditional

K231335 - Cleerly ISCHEMIA (FDA 510(k) Clearance)

K231335 · Cleerly, Inc. · Cardiovascular device
Sep 2023
Decision
123d
Days
Class 2
Risk

K231335 is an FDA 510(k) clearance for the Cleerly ISCHEMIA. This device is classified as a Adjunctive Epicardial Vascular Physiologic Status Indicator (Class II - Special Controls, product code QXZ).

Submitted by Cleerly, Inc. (Denver, US). The FDA issued a Cleared decision on September 8, 2023, 123 days after receiving the submission on May 8, 2023.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2200. 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..

Submission Details

510(k) Number K231335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2023
Decision Date September 08, 2023
Days to Decision 123 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code QXZ - Adjunctive Epicardial Vascular Physiologic Status Indicator
Device Class Class II - Special Controls
CFR Regulation 21 CFR 870.2200
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.