Adjunctive Epicardial Vascular Physiologic Status Indicator
The adjunctive epicardial vascular physiologic status indicator (product code QXZ) is a Class 2 Cardiovascular prescription device (regulation 870.2200) based on sensor technology or image data that provides information to a clinician in detecting the possible presence of functionally significant coronary artery disease, suggesting the need for further testing. Requiring 510(k) clearance, it is intended for adjunctive use alongside other clinical workup and is not intended to quantify the degree of epicardial flow limitation or independently direct therapy. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QXZ
- Device Class
- FDA class 2
- Regulation Number
- 870.2200
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K231335 | Cleerly ISCHEMIA | Sep 08, 2023 | Substantially Equivalent | Cleerly, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.