# K980820: Philips Easyguide

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems, Inc.
- Decided: Oct 13, 1998 after 224 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 K954276 (1996). 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)
- K962939: Vectorvision, Brainlab, Inc. (1997) Summary page 2.
- K965139: Surgical Microscope Navigator (SMN) System/Surgical Tool Navigator (STN) System, Carl Zeiss, Inc. (1997) Summary page 2.
- K954276: Stealthstation, Surgical Navigation Technologies, Inc. (1996) Summary page 2.

## Indications for use
The EasyGuide Neuro (Release 2) option is used for instrument pointing, instrument learning, 3D marker visualization and image rendering when used with the EasyGuide Standard Workstation which is indicated for use in planning neurosurgical procedures and for localizing and navigating during neurosurgical procedures. The EasyTaxis option is used to assist the surgeon in the positioning of instruments and in guiding an instrument to its targeted position during a surgical procedure when used with the EasyGuide Standard Workstation which is indicated for use in planning neurosurgical procedures and for localizing and navigating during neurosurgical procedures. The Easyguide Neuro (Release 2) option and the EasyTaxis option are used for support in neurosurgical procedures such as: Frameless stereotactic procedures Intra-operative resection of brain tumors Biopsies Endoscopic procedures

Source page: https://510kreport.com/device/K980820
Methodology: https://510kreport.com/methodology