APPLICATORS FOR AFTERLOADING BRACHYTHERAPY— 510(k) K082530

Name: FDA 510(k) clearance K082530
Creator: U.S. Food and Drug Administration
Published: 2008-10-30

Substantially Equivalent

Isodose Control B.V.

FDA 510(k) clearance K082530 for APPLICATORS FOR AFTERLOADING BRACHYTHERAPY, Substantially Equivalent on 2008-10-30. 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: 2008-09-02
Decision date: 2008-10-30
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Ede, NL

Download summary PDF View on FDA.gov ↗

Recent devices under product code JAQ

view all

K262383 — LumenCare Azure2026-07-24
K252717 — MAASTRO Rectal Applicator Set2026-05-20
K251037 — Rectal Applicator2025-12-19
K252884 — Guided Aarhus Applicator Set2025-11-19
K250299 — CT/ MR Tandem and Ovoid Set2025-05-09

More clearances from Isodose Control B.V.

view all

K091145 — FLEXIPLAN 3D AND 3D+2009-05-27
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.