# K991706: Virtuoso-Stereotaxic Planning Software

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: Dec 7, 1999 after 202 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: 1 generation back to K892425 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K892425: STP Complete Module Set, Leibinger & Fischer, Ltd. (1990) Summary page 1.

## Indications for use
VIRTUOSO is a software-based planning system used to create treatment plans for radiation therapy with high-energetic phontons. It is used for patients which are selected for a precise radiation therapeutical treatment according to medical diagnosis. It may be used only by radiation therapeutical experts under medical supervision in rooms which are suitable for the operation of computers.

Source page: https://510kreport.com/device/K991706
Methodology: https://510kreport.com/methodology