# K964206: Nucletron Plato External Beam Planning RTS V2 and RTS 3D V2

- Pathway: 510(k) (Traditional)
- Applicant: Nucletron Corp.
- Decided: Jun 20, 1997 after 242 days
- Product code: IYE (Accelerator, Linear, Medical)
- 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 K914926 (1992). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921991: Plato Radiation Therapy Planning System, Nucletron-Oldelft Corp. (1992) Summary page 1.
- K951581: PINNACLE3 Apex, Adac Laboratories (1996) Summary page 1.
- K953391: Treatment Management System, Siemens Medical Solutions USA, Inc. (1996) Summary page 1.

## Most influential descendants
- K980629: VSS, Virtual Simulation System (1998), 0 descendants of its own

## Indications for use
PLATO 3-D Treatment Planning System is used to prepare individual treatment plans for cancer patients undergoing therapeutic radiation treatment. The system is utilized to develop plans for external photon and electron therapy. PLATO External Beam Planning RTS V2 and RTS 3D V2 has intended uses equivalent to its predecessor PLATO RTS V1. This device is used for external beam radiation therapy treatment planning for localization and treatment planning of malignant and benign lesions of patients. Treatment of cancer may require use of external radiation beams from an external source. Teletherapy unit coordinates of beam placement including gantry angle, field size, and shape along with accurately calculated predicted dose computation, are necessary in present day planning for radiotherapy. The ability to calculate both coplanar and noncoplanar beams to a highly accurate level is desirable by the industry. PLATO RTS V 2 allows for accuracy and speed to clinically facilitate this need. The recent use of linear accelerator Multileaf Collimators for field shaping is desired and supported by RTS V2.

Source page: https://510kreport.com/device/K964206
Methodology: https://510kreport.com/methodology