Lunit Inc.
Type:
Software
Method:
Mammography
Subspecialty:
breast
Use Case Category
Assistance in differential diagnosis (CADx), Assistance in detecting alterations (CADe)
Data from Anvisa
Registration Number:
80686360424
Case Number:
25351037774202501
Risk Class:
II
Registration Holder:
Mandala Brasil Importação e Distribuição de Produtos Médico Hospitalar Ltda.
Holder's CNPJ:
91.174.760/0001-81
Manufacturer:
LUNIT, INC.
Country of Manufacture:
South Korea
Publication Date:
2025-04-22
Registration Validity:
In effect
Update Date:
2025-01-07