# K090607: Blue Sky Bio Plan, Version .38

- Pathway: 510(k) (Traditional)
- Applicant: Blue Sky Bio, LLC
- Decided: Apr 22, 2009 after 47 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: 6 generations back to K954678 (1996). 12 ancestors in all.
2 later devices descend 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)
- K060267: Virtual Implant Placement (Vip) Dental  Implant Surgery Planning Software, Implant Logic Systems, Ltd. (2006) Summary page 1.
- K061126: Accurex, Cybermed, Inc. (2006) Summary page 1.

## Most influential descendants
- K190096: R2GATE (2019), 1 descendant of its own
- K223909: R2GATE Lite TM (2023), 0 descendants of its own

## Indications for use
Blue Sky Plan is intended to be used as conversion software for Computed Tomography (CT) generated DICOM images into a format that allows a dentist to assess the anatomic topography of the maxilla and mandible as well as location of important structures. It allows the information to be used for pre-surgical treatment planning of dental implant procedures. The Blue Sky Plan software is deployed on standard personal computer hardware using a Windows operating system.

Source page: https://510kreport.com/device/K090607
Methodology: https://510kreport.com/methodology