Codonics Horizon CI Medical Multimedia Dry Imager; Codonics Horizon GS Medical Multimedia Grey Scale Dry Imager
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K021054 FDA 510(k)
- FDA Product Code
- LMC FDA 510(k)
- Models / Variants
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2040 FDA 510(k)
- Regulation Number
- 892.2040 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Codonics Horizon CI and GS Medical Multimedia Dry Imagers are Camera, Multi Format, Radiological devices designed for capturing and processing radiographic images in a dry, filmless format. These imagers utilize advanced multimedia capabilities to produce both colour (CI) and grayscale (GS) outputs, enabling radiologists to review and archive digital images directly from the imaging modality without the need for wet processing or film.
These devices are intended for use in radiology settings and are supplied as reusable medical equipment, adhering to FDA 510K and MDR regulatory standards. They are classified under Device Class II and are intended for integration with radiological imaging systems, with no specific sterility requirements as they are not single-use. The imagers are compatible with standard radiology workflows and require proper storage in a controlled environment to maintain operational integrity.
Frequently asked questions
What types of radiographic images can the Codonics Horizon CI and GS Medical Multimedia Dry Imagers produce, and how do they differ from each other?
The Codonics Horizon CI Medical Multimedia Dry Imager produces colour radiographic images, while the Horizon GS model generates grayscale outputs. Both devices eliminate the need for wet processing or film by capturing and processing images digitally, enabling radiologists to review and archive them directly from the imaging modality. The choice between CI and GS depends on whether colour differentiation is required for diagnostic purposes.
Are these devices single-use or reusable, and what maintenance considerations should be taken into account?
The Codonics Horizon CI and GS Medical Multimedia Dry Imagers are reusable medical devices, not intended for single-use. Since they are not sterile by design, they must be cleaned and maintained according to manufacturer guidelines to ensure proper functionality and hygiene. Regular upkeep is essential for integration with radiology workflows and to preserve operational integrity.
What regulatory pathways have these devices undergone, and how does that affect their use in clinical settings?
The Codonics Horizon CI and GS Medical Multimedia Dry Imagers have been cleared via the FDA 510(k) pathway and comply with MDR (Medical Device Regulation) standards. This means they are classified as Class II devices and are intended for integration with radiological imaging systems. Their regulatory clearance confirms they meet safety and performance requirements for use in radiology settings, though specific clinical indications are determined by the connected imaging modality.
How should these imagers be stored to ensure they remain operational and reliable?
The Codonics Horizon CI and GS Medical Multimedia Dry Imagers require storage in a controlled environment to maintain their operational integrity. While no specific sterility is required (as they are reusable), they should be kept in a clean, dry space away from extreme temperatures or humidity to prevent damage and ensure consistent performance in radiology workflows.
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: Products - Codonics | Innovator of the Safe Label System®
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 | K021054 | Class II | Active |
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Manufacturer
- Manufacturer
- Codonics Inc.
- FDA Applicant
- Codonics, Inc.
Sources (2)
- FDA 510(k) K021054 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026