# K970604: Viewpoint - 3.0 Software

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: May 19, 1997 after 90 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: 3 generations back to K905070 (1991). 5 ancestors in all.
159 later devices descend from it; 6 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.
- K963221: Optical Digitizer Option for View Point, Philips Medical Systems (Cleveland), Inc. (1997) Summary page 2.

## Most influential descendants
- 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
- K072806: Mako Surgical Tactile Guidance System (TGS) (2008), 78 descendants of its own

## Indications for use
The intended use of the ViewPoint is unchanged by the 3.0 software, but the indications for use have been expanded to include spinal surgical procedures. The intended use and indications for use are as follows: 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-operative procedures. The ViewPoint is indicated for use in: « Intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous) - Spinal surgical procedures involving spinal stabilization, neural decompression, or resection of spinal neoplasms.

Source page: https://510kreport.com/device/K970604
Methodology: https://510kreport.com/methodology