Leksell GammaPlan— 510(k) K173791

Substantially Equivalent

Elekta Instrument AB

FDA 510(k) clearance K173791 for Leksell GammaPlan, Substantially Equivalent on 2018-02-09. Applicant: Elekta Instrument AB.

Clearance details

Applicant: Elekta Instrument AB
Product code: Code IWB
Advisory panel: Radiology
Date received: 2017-12-14
Decision date: 2018-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stockholm, SE

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