Cleerly ISCHEMIA

FDA 510(k) K231335 · Cleerly, Inc.

Substantially Equivalent

510(k) numberK231335

Submission

Device name
Cleerly ISCHEMIA
Applicant
Cleerly, Inc.
Denver, CO, US
Received
May 8, 2023
Decision date
September 8, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
QXZ – Adjunctive Epicardial Vascular Physiologic Status Indicator
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2200
Specialty
Cardiovascular

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…

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Questions and answers

When was Cleerly ISCHEMIA cleared by the FDA?

Cleerly ISCHEMIA (K231335) received a 510(k) decision of Substantially Equivalent on September 8, 2023, 123 days after the submission was received.

What is the product code of K231335?

The FDA product code is QXZ – Adjunctive Epicardial Vascular Physiologic Status Indicator, a Class II (moderate risk) device regulated under 21 CFR 870.2200.