[Digital Breast Tomosynthesis Mammography System Registration Application Data Technical Review Concerns]

Yujing Zhang; Lu Liu; Wei Xu

doi:10.3969/j.issn.1671-7104.2019.04.015

[Digital Breast Tomosynthesis Mammography System Registration Application Data Technical Review Concerns]

Zhongguo Yi Liao Qi Xie Za Zhi. 2019 Jul 30;43(4):290-293. doi: 10.3969/j.issn.1671-7104.2019.04.015.

[Article in Chinese]

Authors

Yujing Zhang¹, Lu Liu¹, Wei Xu¹

Affiliation

¹ Center for Medical Device Evaluation, NMPA, Beijing, 100081.

PMID: 31460724
DOI: 10.3969/j.issn.1671-7104.2019.04.015

Abstract

In this paper, the focus of technical review of the registration application data of digital Breast Tomosynthesis Mammography System was sorted out, so as to provide reference for researchers and manufacturers in China when applying for registration and preparation of such products.

Keywords: digital breast tomosynthesis; the focus of technical review; three-dimensional tomography; two-dimensional synthesis.

MeSH terms

Breast / diagnostic imaging
Breast Neoplasms / diagnostic imaging
China
Humans
Mammography* / instrumentation
Mammography* / standards
Radiographic Image Enhancement / standards
Risk Factors