6018914CE01

EC CERTIFICATE
Full Quality Assurance System
Directive 93/42/EEC on Medical devices, Annex II excluding (4)
ManufacturerKeya Medical Technology Co., Ltd.
Room 301, East Block, Hademen Plaza, No.8-1 Chongwenmenwai Street, Dongcheng District 100062 Beijing P.R.China
For the product category(ies)
Software tool for quantitative analysis of noninvasive Fractional Flow Reserve (FFR) of Coronary Computed Tomography Angiography
This certificate covers the following product(s):
Model: DEEPVESSEL FFR version V1.x.
Status:Valid