# K050341: Implant Location Software, Model 0.1.0

- Pathway: 510(k) (Traditional)
- Applicant: Tactile Technologies, Ltd.
- Decided: Mar 29, 2005 after 46 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 2.

## Indications for use
The Implant Location Software (ILS) is indicated for use by medically trained people as a software interface and image segmentation system for the transfer of imaging information from a CT scanner and as planning software for dental implant placement.

Source page: https://510kreport.com/device/K050341
Methodology: https://510kreport.com/methodology