# K041703: IPLAN!

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Oct 22, 2004 after 122 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K983410 (1999). 5 ancestors in all.
56 later devices descend from it; 2 cite it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020631: IPLAN, Brainlab AG (2002) Summary page 1.

## Most influential descendants
- K053127: IPLAN (2006), 54 descendants of its own
- K052220: Iplan RT Fibertracking (2005), 34 descendants of its own
- 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

## Indications for use
iPlan!'s indications for use is to prepare and present patient and image data based on CT, MR, X-ray (Fluoro), including image preparation image fusion image segmentation where the result is used for the creation of treatment plans for Stereotactic Surgery: - Surgery Planning The Surgery Planning is a tool for pre- and intraoperative stereotactic surgery planning based on stereotactic systems. Multiple graphical display functions and 3-dimensional views of anatomical structures offer effective and efficient means of presenting the anatomical data for diagnostic and surgical planning. Computer-graphic simulation in various views of a chosen probe path can help prevent probe intersections with unwanted, critical structures or vessels. The surgeon can interactively change a probe path simulation through the image slices in the software with on-line calculation of the accompanying arc settings and graphical manipulation to aid in optimizing his approach. - BrainMAP The BrainMAP module is a tool, which defines two and three-dimensional information about anatomical structures of the human brain for pre- and intraoperative planning of stereotactic procedures. These contours are defined and described by Talairach/Tournoux and/or Schaltenbrand/Wahren based brain atlases. The user is provided with information about the position of the various functional and anatomical areas of the brain. These positions of the structures have to be correlated with every patients brain data. The correlation is defined by a procedure defined by Talairach/Tournoux. Using their grid system to divide the brain in particular areas, the program will be able to provide matching data for different patient data. BrainMAP may be used alone or in conjunction with neurosurgery. - Functional Planning The Functional Planning is based on Surgery Planning, which gives two- and three dimensional online information of a stereotactical surgical instrument (electrodes) for a neurosurgical functional treatment using a stereotactic arc. The user is provided with information by numerical results and by various displays and reconstruction planes based on patient images (CT, MRI, PET, SPECT) about the position and orientation relative to the patient of his surgical instrument to perform stimulation and treatment on brain structures or to a preplanned trajectory. The software is capable of displaying the trajectory and functional areas of the brain based on BrainMAP online on the screen and recording the stimulations by storing positions of the electrodes. The Functional Planning is intended to be used with patients where measurement, stimulation and placement of electrodes in the brain (pallidotomy) are part of the treatment. The stereotactic arc system is useful for placing these electrodes or using the instruments during the treatment and in the planning phases of the functional treatment. In addition iPlan!'s indications for use is to prepare and present patient and image data based on CT, MR, X-ray (Fluoro) including image preparation image fusion image segmentation where the result is preplanned data to be used by other BrainLAB medical devices such as VectorVision (for performing the planned treatment) where these medical devices are used for: Image Guided Surgery BrainLAB's Image Guided Surgery system is intended to be an intraoperative image guided localization system to enable minimally invasive surgery where the image guided surgery system is indicated for any medical condition in which the use of stereotactic surgery may be considered to be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, X-ray or MR based model of the anatomy. Example procedures include but are not limited to: Cranial procedures Spine procedures ENT procedures iPlan! 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! FiberTracking can be used with other iPlan! treatment plans and other BrainLAB medical devices such as VectorVision, where this medical device is used for image guided surgery.

Source page: https://510kreport.com/device/K041703
Methodology: https://510kreport.com/methodology