# K051392: Bti-Scan, Version 4.0

- Pathway: 510(k) (Traditional)
- Applicant: B.T.I. Biotechnology Institute, Sl.
- Decided: Jun 29, 2005 after 33 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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 K924630 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033849: Simplant System, Materialise NV (2004) Summary page 1.

## Indications for use
BTI-Scan is indicated for use as a medical front-end software that can be used by medically trained people for the purpose of visualizing gray value images. It is indicated as a software interface and image segmentation system for the transfer of imaging information from a medical CT scanner. It is also indicated for use as a planning and simulation software for dental implant placement and surgical treatment.

Source page: https://510kreport.com/device/K051392
Methodology: https://510kreport.com/methodology