# K052220: Iplan RT Fibertracking

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Sep 30, 2005 after 46 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: 3 generations back to K920879 (1992). 10 ancestors in all.
34 later devices descend from it; 1 cites it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041703: IPLAN!, Brainlab AG (2004) Summary page 1.
- K032511: Intuition Image, Brainlab AG (2004) Summary page 1.

## Most influential descendants
- K080886: Iplan RT Image (2008), 33 descendants of its own
- K103246: Iplan RT (2011), 32 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

## Indications for use
iPlan RT FiberTracking's indications for use is to prepare and present patient and image data based on CT, MR, Angiographic and other imaging sources including - image preparation - image localization - image fusion - image segmentation - isocenter handling - plan review and approval - fiber tracking where the result is used for stereotactic radiation treatment planning that is intended for use in stereotactic, conformal, computer planned, LINAC based radiation treatment of cranial, head and neck and extracranial lesions. Fiber Tracking: iPlan RT FiberTracking's indication for use is to prepare and present patient and image data based on MRI scanned with diffusion-weighted sequences. These diffusion images are used for the calculation and display of fiber bundles in a selected region of interest. The created treatment plans of iPlan RT FiberTracking can be used with other iPlan treatment plans and other BrainLAB medical devices such as BrainSCAN, iPan RT Image, and iPlan RT Dose where this medical device is used for radiotherapy treatment planning.

Source page: https://510kreport.com/device/K052220
Methodology: https://510kreport.com/methodology