Radiology Devices

United States · Last verified: 2026-09-08

Number

21 CFR 892

Type

Regulation

Issuer

U.S. FDA

Status

in_force

Authority

FDA / CDRH

What this covers

放射学器械分类目录：分诊断器械、治疗器械和其他器械，含 X 射线系统、CT、MRI、超声成像、放射治疗设备及影像处理软件等，共 94 个条文。

Source: U.S. Food and Drug Administration (public domain)