# K122427: CS Orthodontic Imaging Software CS Oms Imaging Software

- Pathway: 510(k) (Special)
- Applicant: Carestream Dental, LLC
- Decided: Sep 12, 2012 after 34 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: 4 generations back to K930527 (1993). 5 ancestors in all.
22 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043104: Kodak Orthodontic Imaging and Oms Imaging 8.0, Practiceworks, Inc. (2005) Summary page 1.

## Most influential descendants
- K131570: Orthovision (2013), 19 descendants of its own
- K173094: OrthoVision (2017), 18 descendants of its own
- K192888: EzOrtho (2020), 17 descendants of its own
- K210187: Overjet Dental Assist (2021), 6 descendants of its own
- K202948: EzOrtho (2020), 6 descendants of its own

## Indications for use
CS Orthodontic Imaging and CS OMS Imaging software is indicated for use by orthodontists or oral maxillofacial surgeons and their clinical staff in storing and organizing images, including digital photographs and x-rays. The device includes the capability to trace a digital cephalometric radiograph, analyze the measurements taken and make growth or surgical predictions.

Source page: https://510kreport.com/device/K122427
Methodology: https://510kreport.com/methodology