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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.
Th
e Braster Care app
2.
The Braster device
3.
The Braster AI software
