California

Primary DI

05057056106502

Basic UDI-DI Code

5057056106508J

Reference

A10650

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

Optos plc

The P200DTx Ophthalmoscope is an ultra-widefield digital imaging device capable of capturing a digital image of the retina in an automated manner without mydriasis, scleral depression or contact with the cornea. It is intended to be used by clinical experts to assist in the diagnosis of eye disease or disorders that manifest themselves in the retina The P200DTx is based on SLO technology, where a low power laser is scanned in two dimensions over the retina. Light reflected from the retina is detected and transformed into a digital image. This image may be stored and subsequently reviewed.

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