Kubtec Xpert Series - 20, 40, 80, 80L, 160 and Mozart Cabinet X-ray systems - Mobile specimen x-ray system, digital

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

제공처:

Medilink Pty Limited

수업:

Class I

Manufactured by:

KUB Technologies Inc 111 Research Drive, Stratford, CT, 6615 United States Of America

치료 영역:

42280 - Mobile specimen x-ray system, digital

치료 징후:

Cabinet x-ray systems verified to 0.1 milliroentgen at any point 5cm outside the external surface whereas US FDA 21CFR 1020.40 allows - Emission limit. (i) Radiation emitted from the cabinet x-ray system shall not exceed an exposure of 0.5 milliroentgen in one hour at any point five centimeters outside the external surface

승인 상태:

A

승인 날짜:

2019-05-13