# K983343: Plato Brachytheraphy, Model V. 14.0

- Pathway: 510(k) (Traditional)
- Applicant: Nucletron Corp.
- Decided: Apr 2, 1999 after 191 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: 1 generation back to K911612 (1991). 1 ancestor in all.
85 later devices descend from it; 6 cite it directly.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911612: Nucletron Planning System, Nucletron-Oldelft Corp. (1991) Summary page 1.

## Cited in the summary but kept off the family tree
- K915562: PLATO Brachytherapy Planning System. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K081281: Ocentra Masterplan 3.1 (Ocentra Brachy) (2008), 54 descendants of its own
- K092132: Xio RTP System (2009), 34 descendants of its own
- K083264: Rayautoplan 1.0 (2009), 31 descendants of its own
- K100552: Raystation Version 1.0 (2010), 30 descendants of its own
- K102216: Xio RTP System (2010), 27 descendants of its own

## Indications for use
Brachytherapy planning with PLATO Brachytherapy is intended for use with brachytherapy procedures, i.e. intercavitary, interstitial, intraluminal (including bronchlal) and surface applicator treatments, involving manual or remote afterloading radioactive sources. The software program provides the physician with anatomical and dosimetric information (i.e. radiographs, transverse slices, or 3D coordinates) to determine the positioning and loading of the radioactive sources prior to insertion. The software also provides the treatment time and dose distribution for the specified loading. From this information the patient can be treated with radioactive sources. With remote afterloading brachytherapy treatment planning the PLATO Brachytherapy program exports the treatment data, i.e. treatment times to the remote afterioader. With manual brachytherapy treatment planning the program exports treatment data regarding insertion/removal time, total dose in permanent implantation and dose distributions for patient records. With both types of software the dose grid is exported and can be evaluated in conjunction with the Nucletron PLATO External Beam treatment planning software.

Source page: https://510kreport.com/device/K983343
Methodology: https://510kreport.com/methodology