# K961903: Magellan

- Pathway: 510(k) (Traditional)
- Applicant: Biosense, Ltd.
- Decided: Aug 24, 1998 after 830 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: 1 generation back to K954395 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954395: Carto System, Biosense, Ltd. (1995) Summary page 1.

## Indications for use
The MAGELLAN™ system, which is comprised of a medical workstation, 2 magnetic location system and a range of locatable tools is intended to be used as an image guided neurosurgery navigation system to pre-operatively and intra-operatively perform the following functions: process and display pre-aperatively radiographic images on & monitor; provide intra-operative image control based on the position and orientation of a user ditected tool; allow for the integration and usage of the Blosense magnetic locatiou systcur and a range of different tool attachments; and store/retrieve image data on computer access mediu (c.g. hard disks, archive media) Circumstunces: The MAGELLAN™ system is intended to be used during planning of a procedure, when more than one approach (c.g. cntry point, trajectory, craniotomy size) is being considercd, and also during surgery when: the target or approach is in a region with few anatomical landmarks (e.g. subcortical brain) or with complex anatomy; the target or approach is in a region where normal landmarks have been distorted either by disease or by previous surgery; the target or approach is in close proximity to critical structures) e.g. venous sinuses, air sinuses, blood vessels, nerves) which must be avoided or negotialed, or the target delineation is important and will not move significantly during the implementation of the approach (e.g. skull-based tumors. sinus diseascs, corpus callosotomies). 1Jisease or Conditions: The MAGELLAN™ system is indicated for paticnts who have imaged space occupying lesions or malfunctions (Loth soft tissuc and osscous) in the head.

Source page: https://510kreport.com/device/K961903
Methodology: https://510kreport.com/methodology