(6) Complete item 4e "System model name" by entering the model name of
the CT system (if applicable).
(7) Complete item 4f "Selected components" by entering the name of the
manufacturer, the model number, and the serial number in the spaces indicated for
beam-limiting devices, tables and C1 gantries. If the component has no serial number,
enter the date the item was manufactured in place of the serial number.
(8) Complete item 4g "Other certified components" by entering how many
other certified components you installed in the system. Enter the quantity in the
e. Section 5, Assembler Certification. Figure 4-5 shows the assembler's
Figure 4-5. Section 5.
(1) Read the assembler's certification carefully and in its entirety. The
assembler's certification reads as follows ensure that you understand and have properly
performed the stated actions prior to signing.
"I affirm that all certified components assembled or installed by me for which this report
is being made, were adjusted and tested by me according to the instructions provided
by the manufacturer(s), were of the type required by the diagnostic x-ray performance
standard (21 CFR Part 1020), were not modified to adversely affect performance, and
were installed in accordance with provisions of 21 CFR Part 1020. I also affirm that all
instruction manuals and other information required by 21 CFR Part 1020 for this
assembly have been furnished to the purchaser and within 15 days from the date of
assembly, each copy of this report will be distributed as indicated at the bottom of each
(2) Review all requirements stated in the assembler certification statement
prior to signing block 5b.