# K030821: Simuplan Treatment Planning System, Model V. 7.5

- Pathway: 510(k) (Traditional)
- Applicant: Simuplan S.L.
- Decided: Sep 17, 2003 after 187 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: 2 generations back to K911612 (1991). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983343: Plato Brachytheraphy, Model V. 14.0, Nucletron Corp. (1999) Summary page 2.
- K010784: Plato SRS Stereotactic Radiosurgery Planning System,Model 2.0, Plato Ifs Image Fusion Software, Model 2.1, Nucletron Corp. (2001)

## Most influential descendants
- K093391: Simuplan Treatment Planning System (2009), 1 descendant of its own
- K120551: Simuplan Treatment Planning System (2012), 0 descendants of its own

## 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/K030821
Methodology: https://510kreport.com/methodology