Docket Management
Docket: 01N-0275 - Electronic Products; Performance Standard-Diagnostic X-Ray Systems
Comment Number: EC -5

Accepted - Volume 1

Comment Record
Commentor Mr. Naoki Morooka Date/Time 2003-04-10 01:58:53
Organization Shimadzu Corp.
Category Company

Comments for FDA General
Questions
1. General Comments For last praragraph in item (5) of 1020.32 (k) (Display of Value of AKR and cumulative air kama) [Original Document] Alternatively, the reference location shall be along the beam axis at a point deemed by the manufacturer to represent the intersection of the x-ray beam entrance surface and the patient skin. [My Proposal] Please revise the following proposal. Alternatively, the reference location of any type fluroscopes shall be along the beam axis at a point deemed by the manufacturer to represent the intersection of the x-ray beam entrance surface and the patient skin. [Reason] In some X-ray fluoroscopic table, Source-image receptor distance(SID) is variable. In such case, the value of AKR and cumulative air kama should be calcurated by SID.




EC -5