VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE

Primary DI

18800118000010

Basic UDI-DI Code

88001180RetiAI68

Reference

IFU-DN-CE-05

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

Not Intended For Eu Market

Manufacturer

Mediwhale, Inc

This medical image detection assistant software receives and stores and manages medical image and blood vessel information data of patients. It provides, stores, and manages the results of artificial intelligence analysis on medical image data, and if necessary, medical image data of specific patients can be inquired. Additionally, artificial intelligence results are presented on the patient's retina, glaucoma and cataract diseases about medical image data. It also predicts cardiovascular risk by identifying the structure of the retina and changes in the blood vessels in the retina (the retinal artery, the retinal vein, and the intraretinal microvascular) within the fundus image with artificial intelligence.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).