GAMMAPLAN— 510(k) K051022

Substantially Equivalent

Elekta Instrument AB

FDA 510(k) clearance K051022 for GAMMAPLAN, Substantially Equivalent on 2005-06-01. 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: 2005-04-22
Decision date: 2005-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
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.