# K101627: IPLAN

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Jun 3, 2011 after 359 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: 4 generations back to K983410 (1999). 7 ancestors in all.
12 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053127: IPLAN, Brainlab AG (2006) Summary page 1.

## Most influential descendants
- K113732: Iplan (Iplan Cranial, Iplan Stereotaxy, Iplan Ent, Iplan CMF, Iplan View, Iplan Spine) (2012), 8 descendants of its own
- K170816: Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM (2017), 5 descendants of its own
- K212420: Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio (2021), 3 descendants of its own
- K223106: Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion  (4.5);Fibertracking (2.0);BOLD MRI Mapping  (1.0);Image Fusion Angio  (1.0) (2023), 1 descendant of its own
- K211544: Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization (2021), 1 descendant of its own

## Indications for use
Plan's indications for use are the viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion, atlas assisted visualization and segmentation, intraoperative functional planning where the output can be used eg. with stereotactic image guided surgery or other devices for further processing and visualization. Example procedures include but are not limited to: - Planning and simulation of cranial surgical procedures such as tumor resection, shunt pilacement, minimal-invasive stereotactic interventions, biopsy, planning and simulation of trajectories for stimulation and electrode recording - ENT procedures such as sinus surgery, tumor surgery - Spine procedures such as tumor surgery, pedlicle screw planning, vertebroplasty planning - Plan View is an application which is intended to be used for reviewing existing treatment plans Typical users of Plan are medical professionals, including but not limited to surgeons and radiologists.

Source page: https://510kreport.com/device/K101627
Methodology: https://510kreport.com/methodology