# K080886: Iplan RT Image

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Jun 24, 2008 after 85 days
- Product code: LHN (System, Radiation Therapy, Charged-Particle, 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: 4 generations back to K920879 (1992). 12 ancestors in all.
33 later devices descend from it; 1 cites it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032511: Intuition Image, Brainlab AG (2004) Summary page 1.
- K052220: Iplan RT Fibertracking, Brainlab AG (2005) Summary page 1.
- K053127: IPLAN, Brainlab AG (2006) Summary page 1.

## Most influential descendants
- 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
- K141860: Raystation (2014), 17 descendants of its own

## Indications for use
iPlan RT Image's indications for use is to prepare and present patient and image data based on CT, MR, Angiographic, PET to include standardized uptake values (SUV) and other imaging sources including * image preparation * image localization * image fusion * image segmentation * isocenter handling , plan review and approval 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.

Source page: https://510kreport.com/device/K080886
Methodology: https://510kreport.com/methodology