# K190096: R2GATE

- Pathway: 510(k) (Traditional)
- Applicant: Megagen Implant Co., Ltd.
- Decided: Jun 26, 2019 after 155 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: 7 generations back to K954678 (1996). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090607: Blue Sky Bio Plan, Version .38, Blue Sky Bio, LLC (2009) Summary page 4.

## Most influential descendants
- K223909: R2GATE Lite TM (2023), 0 descendants of its own

## Indications for use
R2GATE is intended for use as a software interface and image segmentation system for the transfer of imaging information from a CBCT scanner. It is also intended as pre-planning software for dental implant placement and surgical treatment.

Source page: https://510kreport.com/device/K190096
Methodology: https://510kreport.com/methodology