# K053164: Iplan Flow

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Mar 23, 2006 after 129 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: 3 generations back to K983410 (1999). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041330: Iplan! Flow, Brainlab AG (2004) Summary page 1.

## Most influential descendants
- K201435: Molecular Flow Simulations (2021), 0 descendants of its own

## Indications for use
iPlan Flow is designed as a planning system for pre- and intraoperative planning of stereotactic or image guided surgery treatments. It is specially designed to display anatomical images of a patient acquired with MR and/or CT as well as images derived from DTI-data acquired with Magnetic Resonance Imaging (MRI). iPlan Flow is a dedicated tool for planning trajectories of intra-cranial catheters. Guidelines for the catheter placement e.g. from catheter suppliers can be visualized and displayed to support the surgeon in improving catheter placement planning. The guidelines, in combination with anatomical information, can be used to suggest areas that are compliant with the guidelines. iPlan Flow does not generate or create rules for the placement of intracranial catheters by any means. iPlan Flow uses MR-DTI and T2-weighted MR images to suggest likely volumes of fluid distribution. The Primary mode of action for iPlan Flow is a device for creating treatment plans for stereotactic or image guided surgical treatment, especially for the creation of plans for the placement of intra-cranial catheters. The treatment plans can be used in conjunction with other BrainLAB medical devices such as VectorVision for image guided surgical treatment.

Source page: https://510kreport.com/device/K053164
Methodology: https://510kreport.com/methodology