Rayscan A-Expert
FDA 510(k)Class II (US FDA 510(k))
by Ray Co., Ltd
Identifiers
- 510(k) Number
- K122918 FDA 510(k)
- FDA Product Code
- MUH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.1800 FDA 510(k)
- Regulation Number
- 872.1800 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Rayscan A-Expert is an extraoral digital dental X-ray system designed for panoramic and optional cephalometric imaging. It utilizes an X-ray generator and tube to produce X-ray beams, while flat panel sensors capture digital images of the teeth, jaw, and oral structures.
This device is authorized under FDA 510(k) clearance K122918. It is classified as a Class 2 radiology device for dental use.
Frequently asked questions
What is the primary function of the Rayscan A-Expert?
The Rayscan A-Expert is an extraoral digital dental X-ray system. It uses an X-ray generator and tube to produce beams, while flat panel sensors capture digital images of a patient's teeth, jaw, and other oral structures.
What imaging capabilities does this system offer?
The system is designed for panoramic imaging as a standard function. It also supports optional cephalometric imaging capabilities to assist in dental diagnostics.
Is this device authorized for use in the United States?
Yes, the Rayscan A-Expert is authorized under FDA 510(k) clearance K122918. It is classified as a Class 2 radiology device intended for dental use.
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: K232325 FDA 510 (k) - RAYSCAN a-Expert | Ray Co., Ltd., RAYSCAN A-EXPERT (K122918) — FDA 510 (k) | Innolitics, RAYSCAN A-EXPERT (K131693) — FDA 510 (k) | Innolitics, RAYSCAN a-Expert3D by RAY Co., Ltd | FDA 510 (k) Summary
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K122918 | Class II | Active |
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Manufacturer
- Manufacturer
- Ray Co., Ltd
- FDA Applicant
- Ray Co., Ltd.
Sources (1)
- FDA 510(k) K122918 24 fields · synced Sep 21, 2026