# K961834: Philips Easyguide Neuro

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems, Inc.
- Decided: Nov 8, 1996 after 179 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 K911783 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942233: MKM (Multiple Coordinate Manipulator) System, Carl Zeiss, Inc. (1994) Summary page 2.
- K951262: Operating Arm System (Oas), Radionics Software Applications, Inc. (1995) Summary page 2.
- K911783: Allegro Viewing Wand, I.S.G. Technologies, Inc. (1994) Summary page 2.

## Indications for use
The EasyGuide is intended for planning neurosurgery and for localizing and navigating during neurosurgery. The EasyGuide facilitates image-supported decisions that may lead to more effective craniotomies, fewer unforeseen complications and shorter surgery times. As an interactive lightbox, Philips EasyGuide Neuro can facilitate image-based decision making. Anatomical structures can be visualized and surgical paths precisely determined before surgery. Decisions on the location and size of a tumor, or an arteriovenous malformation can be made with confidence. Critical areas can be identified and avoided for better access to pathology.

Source page: https://510kreport.com/device/K961834
Methodology: https://510kreport.com/methodology