# K110644: Praezis Plus

- Pathway: 510(k) (Traditional)
- Applicant: Tatramed Spol. S.R.O.
- Decided: May 24, 2012 after 444 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 K892425 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K946033: Leibinger Stereoplan Plus Sterotactic Treatment Plan Ing Software Package, Leibinger GmbH (1995) Summary page 1.

## Indications for use
The Praezis Plus system is computer software intended to be used in planning intracranial stereotactic surgeries such as biopsies and treatment of lesions. The intended user of Praezis Plus is a medical doctor - neurosurgeon.

Source page: https://510kreport.com/device/K110644
Methodology: https://510kreport.com/methodology