
Elekta Instrument AB
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MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE is an FDA 510(k)-cleared medical device (K013861) manufactured by Elekta Instrument AB. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 5, 2001. Regulation: 8.