CS Orthodontic Imaging Software CS OMS Imaging Software
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K122427 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CS Orthodontic Imaging Software is a digital orthodontic imaging solution designed for chairside use in orthodontic practice. It integrates patient photographs and radiographic data to facilitate treatment planning, patient education, and communication of orthodontic treatment options.
This software is intended for use with compatible extraoral imaging systems and operates as a standalone or integrated tool within a dental practice network. It requires compatible hardware and meets specified system requirements for installation, with no indication of sterility or single-use/reusable classification. The device holds FDA 510(k) clearance under Special Review (K122427) and complies with EU MDR regulations.
Frequently asked questions
What types of imaging data can the CS Orthodontic Imaging Software integrate with for treatment planning?
The software is designed to integrate patient photographs and radiographic data, combining visual and imaging information to support orthodontic treatment planning. This integration helps clinicians visualize treatment options and communicate them effectively with patients, though it requires compatible extraoral imaging systems for full functionality.
Is this software meant for standalone use, or does it need to be part of a larger dental practice network?
The CS Orthodontic Imaging Software can function as either a standalone tool or be integrated into a dental practice network, depending on the practice’s hardware setup and system requirements. Its flexibility allows it to adapt to different clinical environments, though compatibility with existing systems may vary.
How is the regulatory status of this software defined, and what does that mean for users?
The software holds FDA 510(k) clearance under Special Review (K122427) and complies with EU MDR regulations. This means it has undergone review by the FDA’s Radiology Advisory Committee and is deemed substantially equivalent to a legally marketed predicate device, ensuring it meets safety and performance standards for orthodontic imaging applications.
Does this software require any specific hardware or system requirements for installation?
Yes, the software has specified system requirements for installation, though these details are not provided in the data. It is designed to work with compatible extraoral imaging systems, so users should verify their practice’s hardware compatibility before installation to ensure seamless integration and functionality.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Orthodontic Imaging Software - Carestream Dental, Improve Your Practice with Carestream Dental Imaging Software, Installing CS Orthodontic Imaging Software, How to Set Up CS Orthodontic Imaging or CS OMS Imaging Integration
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K122427 | Class II | Active |
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Manufacturer
- Manufacturer
- Carestream Dental LLC
- FDA Applicant
- Carestream Dental, LLC
Sources (2)
- FDA 510(k) K122427 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026