Angiographic Coronary Vascular Physiologic Simulation Software
The Angiographic Coronary Vascular Physiologic Simulation Software is a software device intended to aid in the identification of functionally significant cardiovascular disease by simulating coronary vascular physiology based on angiographic data. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 870.1415 in the Cardiovascular specialty. The product code is QEK. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QEK
- Device Class
- FDA class 2
- Regulation Number
- 870.1415
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
Definition
An angiographic coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.