FLEXITRON— 510(k) K070574

Substantially Equivalent

Isodose Control B.V.

FDA 510(k) clearance K070574 for FLEXITRON, Substantially Equivalent on 2007-04-13. Applicant: Isodose Control B.V.. Device class: 2.

Clearance details

Applicant: Isodose Control B.V.
Product code: Code JAQ
Device class: Class 2
Regulation: 21 CFR 892.5700
Advisory panel: Radiology
Date received: 2007-02-28
Decision date: 2007-04-13
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Veenendaal, NL

Download summary PDF View on FDA.gov ↗

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More clearances from Isodose Control B.V.

K091145 — FLEXIPLAN 3D AND 3D+2009-05-27
K082530 — APPLICATORS FOR AFTERLOADING BRACHYTHERAPY2008-10-30
K081112 — FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM2008-07-29

Recalls naming K070574

K-number listed on FDA's recall record

Z-0772-2020 — There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexitron brachytherapy afterloader system. Due to an obstruction during the check cable out drive, the internal guiding tube became displaced and the check cable became damaged. This issue could cause treatment interruption or in a very unlikely scenario, incorrect source positioning and radiation treatment errors.Class II·Terminated·Nucletron BV·20191118

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K070574.

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