# K083264: Rayautoplan 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Raysearch Laboratories AB
- Decided: Jan 22, 2009 after 78 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K862643 (1987). 11 ancestors in all.
31 later devices descend from it; 1 cites it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081281: Ocentra Masterplan 3.1 (Ocentra Brachy), Nucletron Corporation (2008) Summary page 1.

## Most influential descendants
- K100552: Raystation Version 1.0 (2010), 30 descendants of its own
- K120387: Raystation (2012), 22 descendants of its own
- K130617: Raystation (2013), 21 descendants of its own
- K140187: Ray Station (2014), 19 descendants of its own
- K141860: Raystation (2014), 17 descendants of its own

## Recalls of this device
- Oct 10, 2011 · Class II · Z-2444-2012: This notice concerns behavior of the SharePlan that may be unexpected and not clearly described in the user manual. This behavior has not caused patient mistreatment or other incidents. However, the d
- May 30, 2011 · Class II · Z-2378-2012: This field notice concerns two behaviors of the SharePlan (Multiple Fraction Groups and Depth Offset) that may be unexpected and are not clearly described in the user manual. None of these behaviors h

## Indications for use
RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of inchvidually optumized IMRT plans and presents their characteristics to the user ina GUI Among the generated plans, the user selects and clincally approves a treatment plan and exports it electronically to DICOM, for subsequent treatment of the patient The intended users of RayAutoplan shall be clinically qualified staff, such as medical physicists, medical doctors or dosimetrists

Source page: https://510kreport.com/device/K083264
Methodology: https://510kreport.com/methodology