# K990860: Viewpoint Microscope Option

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Mar 30, 1999 after 14 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). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970604: Viewpoint - 3.0 Software, Philips Medical Systems (Cleveland), Inc. (1997) Summary page 2.

## Indications for use
The ViewPoint Microscope Option does not change the existing intended use and indications for use for the ViewPoint as defined below. 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/K990860
Methodology: https://510kreport.com/methodology