# K121466: Guidemia

- Pathway: 510(k) (Traditional)
- Applicant: Guidemia Technologies, LLC
- Decided: May 31, 2012 after 14 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The GuideMia system is intended as software interface to transfer DICOM images generated by CT scanners, an image segmentation system to create dental anatomnies from scan images, and a pre-operative software for simulating/evaluating dental implant placement and surgical treatment options.

Source page: https://510kreport.com/device/K121466
Methodology: https://510kreport.com/methodology