# K062237: Cadi, Version 4

- Pathway: 510(k) (Traditional)
- Applicant: Synca Marketing, Inc.
- Decided: Nov 20, 2006 after 110 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
CADI is a dental imaging software for general dental and maxillo-facial diagnostic. It controls capture, display, treatment, analysis and saving of digital images from x-ray units, intraoral or extraoral dental camera, digital cameras, and images acquired by digitizing film with a scanner, in order to enable a dentist to diagnose the dental health of a patient. CADI is a modular software, meaning that it offers dentistry professionals the choice to activate specific modules, depending on the type of image sources they use. These modules are as follows: Digital x-ray module: This module features a 16-bit x-ray viewer and imaging tools used to enhance the image quality of x-rays taken by sensors or phosphor plate systems. Intraoral Camera Module: CADI automatically enhances images captured by intraoral cameras and sorts them by tooth number. Digital Camera Module: This module allows importing digital camera images, and sorts them in order in a patient file. Printouts are automatically sorted in AAO order, or any custom order. This module also crops and prints images. Cosmetic and Whitening Module: CADI simulates whitening results in minutes to help build an in-office program for patients. It also provides cosmetic makeover simulations using a library of natural smile images. Natural Smiles Library: Smiles library that sorts images in a logical order, including images for a range of ethnic backgrounds. Orthocephalometric Tracing (DFO) Module: CADI DFO uses point location tools and a tutor window to help achieve cephalometric tracings. It includes most current and popular tracing analysis, and allows the user to create his/her own analysis. CADI is a prescription use only product, intended to be used by dental professionals only.

Source page: https://510kreport.com/device/K062237
Methodology: https://510kreport.com/methodology