1. DESCRIPTION AND INTENDED USE
1.1. DESCRIPTION
The Braster Pro – breast examination system, hereinafter referred
to as the "Braster Pro", is a medical device intended for
thermographic breast examination. The system is available in two
versions: Basic and Premium. The system in both versions consists
of:
the Braster device, which is composed of:
•
-
the image acquisition device, and
-
three thermographic matrices;
the Braster Care mobile app;
•
the Braster AI automatic interpretation software.
•
Fig. 1: Components of the Braster Pro:
1.
e Braster Care app
2. The Braster device
3. The Braster AI software
11
Th