Devices · Cleerly, Inc

Cleerly ISCHEMIA

Cleerly, Inc is listed for Cleerly ISCHEMIA (K231335). The FDA list gives September 8, 2023 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code QXZ as “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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231335

Official FDA database record

Date of final decision

September 8, 2023

Company on the FDA list

Cleerly, Inc

Lead panel

Cardiovascular

Primary product code

QXZ

openFDA device name for the code

Adjunctive Epicardial Vascular Physiologic Status Indicator

Device class

2

Regulation number

870.2200

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary