Decision 2009/12/EC is amended as follows:

1. (1)

   in Article 1, the following point (g) is added:

   1. ‘(g)

      the “Automatic ultrasound instrument (AutoFOM III)” apparatus and the assessment methods related thereto, details of which are given in Part 7 of the Annex.’;

2. (2)

   the Annex is amended in accordance with the Annex to this Decision.