# K981480: Philips Easyguide

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems, Inc.
- Decided: Jan 28, 1999 after 279 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 K905070 (1991). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970865: Isg Family of Viewing Wands, I.S.G. Technologies, Inc. (1997) Summary page 2.
- K970604: Viewpoint - 3.0 Software, Philips Medical Systems (Cleveland), 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 Philips EasyGuide is a viewing and navigation tool for all cranial surgical processes such as • Tumor resection: Meningioma, Glioma, Pituitary tumor, Skull base tumor, Metastasis • Treatment of vascular malformations, aneurysms • Transnasal approaches The EasyGuide Standard Workstation with Spine option is intended for planning spine surgery and for localizing and navigating during spine surgery. EasyGuide Spine is specially designed for spinal application areas such as: • Stabilization techniques • Tumor resection

Source page: https://510kreport.com/device/K981480
Methodology: https://510kreport.com/methodology