DIVE Automatic visual exam and screening

Primary DI

8437021711011

Basic UDI-DI Code

8437021711004DIVE01WF

Reference

DIVE Device for automatic visual exam and screening

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

DIVE MEDICAL S.L

The DIVE device features a high-resolution touchscreen for visual stimuli display, an eye tracker to capture the patient’s response to those stimuli, and an ergonomic adjustable case designed for optimal positioning of the device. DIVE is a diagnostic aid medical device that allows to perform an automatic examination and screening of the visual function even in pre-verbal or non-verbal patients. It has two modes of operation or modules running on the same technology, but with a slightly different purpose: • Vision Exam provides accurate metrics from different vision exploration tests to make it easier for ophthalmologists, optometrists, and orthoptists to make diagnosis and follow-up with objective data. • AI Vision Screening incorporates to the metrics obtained from a predefined sequence of test an algorithm based on artificial intelligence to help to estimate the potential presence of visual problems for vision screening purposes. The screening mode is useful for healthcare professionals to identify children with potential visual problems, facilitating referral to the specialist. DIVE with Surface Pro 7 i3/4GB/128GB and eye tracker IS5. Software version 1.0.

The Basic UDI-DI associated with this device has 20 devices in total. Below are some other devices sharing the same Basic UDI-DI.

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