# K120551: Simuplan Treatment Planning System

- Pathway: 510(k) (Traditional)
- Applicant: Simuplan S.L.
- Decided: Jun 8, 2012 after 106 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.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093391: Simuplan Treatment Planning System, Simuplan S.L. (2009) Summary page 1.

## Cited in the summary but kept off the family tree
- K082636: TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3T, Quality Electrodynamics (2008). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
SIMUPLAN Treatment Planning System is intended for use in preparing individual treatment plans for patients undergoing radiation therapy treatment with external beam or brachytherapy. The program output does not directly treat the patient; all information must be confirmed by the physician prior to treatment.

Source page: https://510kreport.com/device/K120551
Methodology: https://510kreport.com/methodology