FDA-Device2012-09-19Class II

Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.

Elekta, Inc.
Hazard

Information released with the product Agility did not originally contain information on compatibility with the add-on Dynamic Multileaf Collimator Apex.

Sold states
Nationwide Distribution including DC & MD
Affected count
2
Manufactured in
4775 Peachtree Industrial Blvd, Bldg 300, #300, Norcross, GA, United States
Products
Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2340-2012

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