# K963221: Optical Digitizer Option for View Point

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Jan 10, 1997 after 147 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: 2 generations back to K905070 (1991). 4 ancestors in all.
160 later devices descend from it; 2 cite it directly.
0 of 165 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961168: Viewpoint, Philips Medical Systems (Cleveland), Inc. (1996) Summary page 2.

## Most influential descendants
- K970604: Viewpoint - 3.0 Software (1997), 159 descendants of its own
- K984298: Z Kat Flurotactic Guidance System Mki (1999), 152 descendants of its own
- K013025: Modification to Flourolab Plus (2001), 151 descendants of its own
- K031454: Acumen Surgical Navigation System (2004), 146 descendants of its own
- K031337: Acumen Surgical Navigation System (2003), 81 descendants of its own

## Indications for use
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).

Source page: https://510kreport.com/device/K963221
Methodology: https://510kreport.com/methodology