# K091145: Flexiplan 3D and 3D+

- Pathway: 510(k) (Special)
- Applicant: Isodose Control B.V.
- Decided: May 27, 2009 after 37 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: 3 generations back to K911612 (1991). 4 ancestors in all.
2 later devices descend 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)
- K081112: Flexiplan Brachytherapy Treatment Planning System, Isodose Control B.V. (2008) Summary page 1.

## Most influential descendants
- K123263: Hdrplus, Add in Prostate Module for Hdrplus (2013), 1 descendant of its own
- K141900: Sagiplan, Sagiplan Prostate Module Add on, Sagiplan Including Prostate Module (2015), 0 descendants of its own

## Indications for use
Flexiplan is a Brachytherapy Treatment Planning System used by medical professionals. Flexiplan is used for the creation of HDR or PDR treatment plans for remote afterloader based brachytherapy. It especially supports the Flexitron Remote Afterloader from Isodose Control, Flexiplan calculates a proposed treatment course based on imported clinical images and other user entered data. Flexiplan supports the evaluation of clinical images in calculating the local and global dose to organs at risk and target volume.

Source page: https://510kreport.com/device/K091145
Methodology: https://510kreport.com/methodology