510(k) Report

FDA applicant

Eckert & Ziegler Bebig GmbH

Berlin, DE4 decisions2013–20151 recall

FDA records 4 decisions for Eckert & Ziegler Bebig GmbH (Berlin, DE) from 2013 to 2015: 4 510(k) clearances. Most are in product codes MUJ (System, Planning, Radiation Therapy Treatment) and JAQ (System, Applicator, Radionuclide…). Its devices cite 7 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Eckert & Ziegler Bebig GmbH’s devices, and how often a recall has named them.

FDA decisions per year

2in 2015

2013: 12014: 12015: 2
2013high 2 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2023

2023: 1
2013high 1 (2023) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Eckert & Ziegler Bebig GmbH by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Eckert & Ziegler Bebig GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MUJSystem, Planning, Radiation Therapy Treatment2decisions
  • JAQSystem, Applicator, Radionuclide, Remote-Controlled1decision
  • KXKSource, Brachytherapy, Radionuclide1decision

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K123263Hdrplus, Add in Prostate Module for HdrplusEckert & Ziegler Bebig GmbH · 20131cites it

What has FDA decided for it lately?

  • K141900Sagiplan, Sagiplan Prostate Module Add on, Sagiplan Including Prostate ModuleEckert & Ziegler Bebig GmbH · 20151 recall
  • K142986SagiNovaEckert & Ziegler Bebig GmbH · 2015
  • K140849IsoseedEckert & Ziegler Bebig GmbH · 2014
  • K123263Hdrplus, Add in Prostate Module for HdrplusEckert & Ziegler Bebig GmbH · 2013

All 4 as Eckert & Ziegler Bebig GmbH →

What has been recalled?

1 recall linked to its devices; the latest:

  • K141900SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning SystemOct 17, 2023Class II