510(k) · Cleared
ClearedPhilips Easyguide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Jan 28, 1999 as substantially equivalent to K970865 (I.S.G. Technologies, Inc., 1997) and 3 other predicates after a 279-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- Jan 28, 1999
- Review
- 279 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K905070 (1991). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 3 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 2 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 1 generation backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- This deviceK981480 Philips EasyguidePhilips Medical Systems, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −3 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −2 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −1 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| 0 (this device) | K981480 | Philips Easyguide | Philips Medical Systems, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HAW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K970865 | Isg Family of Viewing WandsSummary page 2…y. SUBSTANTIAL EQUIVALENCE INFORMATION: The Philips EasyGuide Standard Workstation with the Spine option is considered substantially equivalent to the ISG Viewing Wand (K970865), the Picker ViewPoint (K970604), the Zeiss Surgical Microscope Navigator (SMN) (K965139) and the Sofamor Danek StealthStation (K… | 1997 |
| * | K970604 | Viewpoint - 3.0 SoftwareSummary page 2…RMATION: The Philips EasyGuide Standard Workstation with the Spine option is considered substantially equivalent to the ISG Viewing Wand (K970865), the Picker ViewPoint (K970604), the Zeiss Surgical Microscope Navigator (SMN) (K965139) and the Sofamor Danek StealthStation (K954276). SAFETY INFORMATION: Th… | 1997 |
| * | K965139 | Surgical Microscope Navigator (SMN) System/Surgical Tool Navigator (STN) SystemSummary page 2…the Spine option is considered substantially equivalent to the ISG Viewing Wand (K970865), the Picker ViewPoint (K970604), the Zeiss Surgical Microscope Navigator (SMN) (K965139) and the Sofamor Danek StealthStation (K954276). SAFETY INFORMATION: The Philips EasyGuide Standard Workstation with Spine optio… | 1997 |
| * | K954276 | StealthstationSummary page 2…uivalent to the ISG Viewing Wand (K970865), the Picker ViewPoint (K970604), the Zeiss Surgical Microscope Navigator (SMN) (K965139) and the Sofamor Danek StealthStation (K954276). SAFETY INFORMATION: The Philips EasyGuide Standard Workstation with Spine option is designed to comply with applicable require… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 11 ancestors has a recall of any class.
- 1 other device also cites its predicate K970865.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
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
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981480 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981480: Philips Easyguide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981480
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026