Ajụjụ metụtara ntuziaka · Ọkara Ọkwa

Iwu FDA nke ajụjụ ngwaọrụ ahụike AI

Na-anwale ụzọ 510 (k), De Novo na PMA, atụmatụ njikwa mgbanwe ekpebiela maka mmelite AI, yana ka iwu EU MDR na AI Act si emetụta ngwaọrụ AI.

Ajụjụ 1 nke 8

What must a manufacturer show to obtain 510(k) clearance?