Patient positioning/tracking video camera system application software

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

AA-Med Pty Ltd

Class:

Class I

Manufactured by:

Volpara Health Technologies Limited Level 14 Simpl House 40 Mercer Street, Wellington Central, Wellington, 6011 New Zealand

Therapeutic area:

47817 - Patient positioning/tracking video camera system application software

Therapeutic indications:

The device is a software solution that receives raw data from digital breast and tomosynthesis x-ray systems; pseudonymizes the data; for each image calculates breast positioning metrics, testing them for adequacy and compression pressure; and for each study calculates a vPGMI score. It displays adjunctive information intended to assist technologists in determining if images are of high quality. It is not a diagnostic aid.

Authorization status:

A

Authorization date:

2020-02-26