//(1)(i) Fluoroscopic equipment manufactured before June 10, 2006//

* Shall be provided with means to preset the cumulative irradiation time of the fluoroscopic tube.
** The maximum cumulative time of the timing device shall not exceed 5 minutes without resetting.
** A signal audible to the fluoroscopist shall indicate the completion of any preset cumulative irradiation-time. 
** Such signal shall continue to sound while x-rays are produced until the timing device is reset.
** Fluoroscopic equipment may be modified in accordance with 1020.30(q) to comply with the requirements of 1020.32(h)(2).
** When the equipment is modified, it shall bear a label indicating the statement:
** ''Modified to comply with 21 CFR 1020.32(h)(2).''

* (ii) As an alternative to the requirements of this paragraph, radiation therapy simulation systems may be provided with a means to indicate the total cumulative exposure time during which x-rays were produced, and which is capable of being reset between x-ray examinations.
bag
fda_public
created
Fri, 20 Nov 2015 11:42:19 GMT
creator
dirkjan
modified
Fri, 20 Nov 2015 11:44:00 GMT
modifier
dirkjan