LEKSELL GAMMAPLAN— 510(k) K061540

Substantially Equivalent

Elekta Instrument AB

FDA 510(k) clearance K061540 for LEKSELL GAMMAPLAN, Substantially Equivalent on 2006-07-05. Applicant: Elekta Instrument AB. Device class: 2.

Clearance details

Applicant: Elekta Instrument AB
Product code: Code IWB
Device class: Class 2
Regulation: 21 CFR 892.5750
Advisory panel: Radiology
Date received: 2006-06-05
Decision date: 2006-07-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Stockholm, SE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.