# K053584: Iplan RT Dose

- Pathway: 510(k) (Special)
- Applicant: Brainlab AG
- Decided: Jul 12, 2006 after 201 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K920879 (1992). 3 ancestors in all.
60 later devices descend from it; 2 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994413: Brainscan, Brainlab AG (2000) Summary page 1.

## Most influential descendants
- K080888: Modeification to Iplan RT Dose (2008), 33 descendants of its own
- K103246: Iplan RT (2011), 32 descendants of its own
- K080799: Atlas-Based Autosegmentation (2008), 29 descendants of its own
- K120387: Raystation (2012), 22 descendants of its own
- K130617: Raystation (2013), 21 descendants of its own

## Recalls of this device
- Nov 19, 2014 · Class II · Z-0957-2015: iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets.
- Nov 19, 2014 · Class II · Z-0956-2015: iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets.
- Jun 5, 2007 · Not classified · Z-1010-2007: Target Alignment Error : A mechanical component/software incompatibility caused by a specific combination of the BrainLAB Target Positioner version 40700-3A for Leksell headrings and BrainLAB planning

## Indications for use
iPlan RT Dose is a stereotactic radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.

Source page: https://510kreport.com/device/K053584
Methodology: https://510kreport.com/methodology