SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE— 510(k) K141900

Name: FDA 510(k) clearance K141900
Creator: U.S. Food and Drug Administration
Published: 2015-05-20

Substantially Equivalent

Eckert & Ziegler Bebig GmbH

FDA 510(k) clearance K141900 for SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE, Substantially Equivalent on 2015-05-20. Applicant: Eckert & Ziegler Bebig GmbH. Device class: 2.

Clearance details

Applicant: Eckert & Ziegler Bebig GmbH
Product code: Code MUJ
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2014-07-14
Decision date: 2015-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Veenendaal, NL

Download summary PDF View on FDA.gov ↗

Recent devices under product code MUJ

view all

K260750 — Virtual Cone (1.0)2026-07-08
K253050 — RadOncAI2026-06-18
K260207 — Multimodality Simulation Workspace (MM Sim) (v1.0.0)2026-05-27
K252784 — eXaSkin Plus2026-05-22
K253078 — ART.1-US2026-05-14

More clearances from Eckert & Ziegler Bebig GmbH

view all

K142986 — SagiNova2015-04-17
K140849 — ISOSEED2014-07-02
K123263 — HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS2013-04-04

Recalls naming K141900

K-number listed on FDA's recall record

Z-0517-2024 — SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning SystemClass II·Ongoing·Bebig Isotopentechnik Gmbh·20231017

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141900.

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