FLEXIPLAN 3D AND 3D+— 510(k) K091145

Substantially Equivalent

Isodose Control B.V.

FDA 510(k) clearance K091145 for FLEXIPLAN 3D AND 3D+, Substantially Equivalent on 2009-05-27. 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: 2009-04-20
Decision date: 2009-05-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Ede, NL

Download summary PDF View on FDA.gov ↗

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More clearances from Isodose Control B.V.

K082530 — APPLICATORS FOR AFTERLOADING BRACHYTHERAPY2008-10-30
K081112 — FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM2008-07-29
K070574 — FLEXITRON2007-04-13

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