510(k) · Cleared
ClearedOptical Digitizer Option for View Point
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems (Cleveland), Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Jan 10, 1997 as substantially equivalent to K961168 (Philips Medical Systems (Cleveland), Inc., 1996) after a 147-day review. Its family tree reaches back 2 generations to 1991. 160 later devices descend from it.
- Decided
- Jan 10, 1997
- Review
- 147 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K905070 (1991). 4 ancestors in all. 160 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 1 generation backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- This deviceK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- Descendant · cites it directly · 159 of its ownK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- Descendant · 2 generations on · 152 of its ownK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- Descendant · 3 generations on · 151 of its ownK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- Descendant · 4 generations on · 146 of its ownK031454 Acumen Surgical Navigation SystemBiomet, Inc. · 2004
- Descendant · 4 generations on · 81 of its ownK031337 Acumen Surgical Navigation SystemBiomet, Inc. · 2003
Showing 5 of 160 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 160 · See all- K970604Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997 · cites it directly159descendants
- K984298Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999 · 2 generations on152descendants
- K013025Modification to Flourolab PlusZ-Kat, Inc. · 2001 · 3 generations on151descendants
- K031454Acumen Surgical Navigation SystemBiomet, Inc. · 2004 · 4 generations on146descendants
- K031337Acumen Surgical Navigation SystemBiomet, Inc. · 2003 · 4 generations on81descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −1 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| 0 (this device) | 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 | — |
| +2 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| +3 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| +4 | K031454 | Acumen Surgical Navigation System | Biomet, Inc. | 2004 | — |
| +4 | K031337 | Acumen Surgical Navigation System | Biomet, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 6 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 6 | 0 |
| 2016 | 5 | 0 |
| 2017 | 11 | 0 |
| 2018 | 2 | 0 |
| 2019 | 10 | 0 |
| 2020 | 12 | 0 |
| 2021 | 9 | 0 |
| 2022 | 14 | 0 |
| 2023 | 20 | 0 |
| 2024 | 14 | 0 |
| 2025 | 18 | 0 |
| 2026 | 11 | 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? (1)
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 |
|---|---|---|---|
| * | K961168 | ViewpointSummary page 2…ewPoint. 4. Safety and Effectiveness The ViewPoint System with the Optical Digitizer Option is substantially equivalent to the ViewPoint System described in the 510(k) K961168 in safety and effectiveness. The following chart has been compiled to demonstrate the Optical Digitizer’s substantial equivalence… | 1996 |
What descends from it? (160)
See all 1602 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 6 years and passes through 1 company; a new generation was cleared every 5.4 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K970604 (Philips Medical Systems (Cleveland), Inc., 1997) has gone furthest, with 159 descendants of its own.
- 1 other device also cites its predicate K961168.
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 Optical Digitizer Option for ViewPoint does not change the intended use of the ViewPoint system.
The ViewPoint is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous).
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/K963221 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963221: Optical Digitizer Option for View Point.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963221
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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