RAYSCAN A-Expert 3D
FDA 510(k)Class II (US FDA 510(k))
by Ray Co., Ltd
Identifiers
- 510(k) Number
- K142247 FDA 510(k)
- FDA Product Code
- OAS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1750 FDA 510(k)
- Regulation Number
- 892.1750 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The RAYSCAN A-Expert 3D is a panoramic X-ray imaging system with cephalostat, classified as an extraoral source X-ray device for dental use. It is designed to capture detailed radiographic images of the teeth, jaw, and surrounding oral structures, including panoramic views, cephalometric assessments, and cone-beam computed tomography (CBCT) scans. This device supports comprehensive dental diagnostics, such as implant planning, temporomandibular joint (TMJ) studies, and orthodontic evaluations.
This system is intended for use in dental clinics and oral healthcare settings, providing both panoramic and 3D imaging capabilities. It operates as a reusable medical device, adhering to regulatory standards outlined in the FDA’s 510(k) clearance process under the classification of Class II (OAS product code). The device requires proper calibration, maintenance, and adherence to radiation safety protocols. No specific sterility or single-use designation is indicated in the regulatory data.
Frequently asked questions
What types of dental imaging can the RAYSCAN A-EXPERT 3D perform, and how does it benefit dental diagnostics?
The RAYSCAN A-EXPERT 3D is designed to capture panoramic X-ray images, cephalometric assessments, and cone-beam computed tomography (CBCT) scans. This versatility supports comprehensive dental diagnostics, including implant planning, temporomandibular joint (TMJ) studies, and orthodontic evaluations by providing detailed views of teeth, jaws, and surrounding oral structures.
Is the RAYSCAN A-EXPERT 3D a single-use or reusable device, and what does this mean for maintenance?
The RAYSCAN A-EXPERT 3D is classified as a reusable medical device. This means it is intended for repeated use in clinical settings, requiring proper calibration, maintenance, and adherence to radiation safety protocols to ensure consistent performance and patient safety.
What regulatory pathway was followed for the RAYSCAN A-EXPERT 3D, and what does this imply for its use?
The RAYSCAN A-EXPERT 3D received FDA clearance through a 510(k) submission, classified as Class II under the OAS (Extraoral Source X-Ray) product code. This indicates the device was determined to be substantially equivalent to a legally marketed predicate and adheres to regulatory standards for dental X-ray imaging systems.
Does the RAYSCAN A-EXPERT 3D require any special handling or storage conditions?
The device data does not specify sterility or special storage requirements beyond standard radiation safety protocols. Since it is reusable, it should be stored in a clean, controlled environment to prevent contamination and ensure proper functionality. Radiation safety measures, such as shielding and compliance with local regulations, must also be followed.
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: RAYSCAN a-Expert3D by RAY Co., Ltd | FDA 510 (k) Summary, RAYSCAN A-EXPERT 3D (K142247) — FDA 510 (k) | Innolitics, RAYSCAN A-EXPERT 3D (K131695) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142247 | Class II | Active |
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Manufacturer
- Manufacturer
- Ray Co., Ltd
- FDA Applicant
- Ray Co., Ltd.
Sources (1)
- FDA 510(k) K142247 24 fields · synced Sep 20, 2026