LEKSELL GAMMAPLAN 4C WITH MULTIVIEW— 510(k) K042269

Name: FDA 510(k) clearance K042269
Creator: U.S. Food and Drug Administration
Published: 2004-09-08

Substantially Equivalent

Elekta Instrument AB

FDA 510(k) clearance K042269 for LEKSELL GAMMAPLAN 4C WITH MULTIVIEW, Substantially Equivalent on 2004-09-08. Applicant: Elekta Instrument AB. Device class: 2.

Clearance details

Applicant: Elekta Instrument AB
Product code: Code MUJ
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2004-08-23
Decision date: 2004-09-08
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.