FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM— 510(k) K081112

Name: FDA 510(k) clearance K081112
Creator: U.S. Food and Drug Administration
Published: 2008-07-29

Substantially Equivalent

Isodose Control B.V.

FDA 510(k) clearance K081112 for FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM, Substantially Equivalent on 2008-07-29. Applicant: Isodose Control B.V.. Device class: 2.

Clearance details

Applicant: Isodose Control B.V.
Product code: Code MUJ
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2008-04-18
Decision date: 2008-07-29
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Veenendaal, NL

Download summary PDF View on FDA.gov ↗

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