# K141900: Sagiplan, Sagiplan Prostate Module Add on, Sagiplan Including Prostate Module

- Pathway: 510(k) (Traditional)
- Applicant: Eckert & Ziegler Bebig GmbH
- Decided: May 20, 2015 after 310 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K911612 (1991). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123263: Hdrplus, Add in Prostate Module for Hdrplus, Eckert & Ziegler Bebig GmbH (2013) Summary page 4.

## Recalls of this device
- Oct 17, 2023 · Class II · Z-0517-2024: Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements.

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

Source page: https://510kreport.com/device/K141900
Methodology: https://510kreport.com/methodology