# K123263: Hdrplus, Add in Prostate Module for Hdrplus

- Pathway: 510(k) (Abbreviated)
- Applicant: Eckert & Ziegler Bebig GmbH
- Decided: Apr 4, 2013 after 168 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K911612 (1991). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091145: Flexiplan 3D and 3D+, Isodose Control B.V. (2009) Summary page 2.

## Most influential descendants
- K141900: Sagiplan, Sagiplan Prostate Module Add on, Sagiplan Including Prostate Module (2015), 0 descendants of its own

## Indications for use
HiDRplus is a Brachytherapy Treatment Planning System used by medical professionals. HDRplus is used for the creation of treatment plans for remote afterloader based HDR and PDR brachytherapy. HDRplus will calculate a proposed treatment course based on imported clinical images and other user entered data. HDRplus also supports the evaluation of clinical images in calculating the local and global doses to organs at risk and target volumes. HDRplus especially supports the Multisource and Gynesource Brachytherapy Remote Controlled Afterloading Devices from Eckert & Ziegler BEGIB GnbH.

Source page: https://510kreport.com/device/K123263
Methodology: https://510kreport.com/methodology