//(g) Source-skin distance//

* (1) Means shall be provided to limit the source-skin distance to
** not less than 38 cm on //stationary// fluoroscopes and to 
** not less than 30 cm on //mobile and portable// fluoroscopes.
** In addition, for fluoroscopes intended for specific surgical application that would be prohibited at the source-skin distances specified in this paragraph, //provisions may be made// for operation at shorter source-skin distances but in //''no case less than 20 cm''//. When provided, the manufacturer must set forth precautions with respect to the optional means of spacing, in addition to other information as required in 1020.30(h).

* (2) For stationary, mobile, or portable C-arm fluoroscopic systems manufactured on or after June 10, 2006, having a maximum source-image receptor distance of less than 45 cm, means shall be provided to limit the source-skin distance to not less than 19 cm. Such systems shall be labeled for extremity use only. In addition, for those systems intended for specific surgical application that would be prohibited at the source-skin distances specified in this paragraph, provisions may be made for operation at shorter source-skin distances but in no case less than 10 cm. When provided, the manufacturer must set forth precautions with respect to the optional means of spacing, in addition to other information as required in 1020.30(h).
bag
fda_public
created
Fri, 20 Nov 2015 11:35:31 GMT
creator
dirkjan
modified
Fri, 20 Nov 2015 11:38:36 GMT
modifier
dirkjan