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FDA PRODUCT CODE · CLASS II

QEK — Angiographic Coronary Vascular Physiologic Simulation Software

An angiographic coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.

DEVICE CLASS
Class II
REGULATION
21 CFR 870.1415
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

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Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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