//(1) Limitation of useful beam//
The fluoroscopic imaging assembly shall be provided with a primary protective barrier which intercepts the entire cross section of the useful beam at any [[SID]].

The x-ray tube used for fluoroscopy shall not produce x-rays unless the barrier is in position to intercept the entire useful beam.

The [[AKR]] due to transmission through the barrier with the attenuation block in the useful beam combined with radiation from the fluoroscopic image receptor shall not exceed 3.34 * 10-3 percent of the entrance AKR, at a distance of 10 cm from any accessible surface of the fluoroscopic imaging assembly beyond the plane of the image receptor.

Radiation therapy simulation systems shall be exempt from this requirement provided the systems are intended only for remote control operation and the manufacturer sets forth instructions for assemblers with respect to control location as part of the information required in [[1020.30(g)]].

Additionally, the manufacturer shall provide to users, under [[1020.30(h)(1)(i)]], precautions concerning the importance of remote control operation.
bag
fda_public
created
Fri, 20 Nov 2015 10:22:04 GMT
creator
dirkjan
modified
Fri, 20 Nov 2015 10:22:39 GMT
modifier
dirkjan