Leksell GammaPlan— 510(k) K151666

Substantially Equivalent

Elekta Instrument AB

FDA 510(k) clearance K151666 for Leksell GammaPlan, Substantially Equivalent on 2015-09-03. Applicant: Elekta Instrument AB.

Clearance details

Applicant: Elekta Instrument AB
Product code: Code MUJ
Advisory panel: Radiology
Date received: 2015-06-19
Decision date: 2015-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stockholm, SE

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