Registration Requirements - Agilent Technologies Medalist x6000 Operator Instructions Manual

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Registration Requirements

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The Medalist x6000 is classified as a "Cabinet X-Ray
System" by the United States Code of Federal Regulations:
21 CFR 1020.40 (X-Ray). The Medalist x6000 is designed,
manufactured and registered in accordance with strict
criteria established by the Department of Health and
Human Services, Food and Drug Administration, Center for
Devices and Radiological Health (CDRH), Department of
Health and Human Services (DHHS), X-ray Products
Branch. Agilent certifies that the Medalist x6000 X-ray
emissions are less than United States Government and
International Safety Standards for a "Cabinet X-ray
Systems."
The Medalist x6000 is enclosed in shielding that limits X-
ray exposure to normal background levels and all of the
Medalist x6000 access ports are safety interlocked to
prevent any accidental radiation exposure. In addition,
Agilent performs an X-ray safety test two times on every
system prior to customer use:
During manufacturing.
At the user's facility.
Agilent further warrants and certifies that the Medalist
x6000 fully passes the approved Certification Test for
compliance with 21 CFR 1020.40 after shipping and
installation at the customer's facility.
Several Medalist x6000s are currently in operation
throughout the world. These systems meet local and
government X-ray exposure standards.
Customers are directed to check with their state radiation
control program director for registration requirements.
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