3.
What information is entered in Section 2 of the Form FDA 2579?
a. Information about the place the unit was installed or assembled.
b. Information about the person installing or assembling the unit.
c.
Information about the components installed or assembled.
d. General information about the system installed or assembled.
4.
When you sign off on Section 5 of the Form FDA 2579, to what are you attesting?
a. You tested and adjusted, did not modify, and installed the system in
accordance with 21 CFR part 1020.
b. You assembled/installed the system in accordance with the manufacturer's
instructions.
c.
You supervised in the assembly/installation of the certified X-ray system.
d. You assembled/installed a non-certified X-ray system or non-certified
components to an existing system.
5.
When is the installation of a certified X-ray system complete?
a. When you complete the Form FDA 2579.
b. When you process the Form FDA 2579.
c.
When the system has been is tested, adjusted, calibrated, and accepted by
the user.
d. When the USAMMA has reviewed the Form FDA 2579 and determined it is in
compliance with 21 CFR Part 1-20.
MD0351
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