Identifiers
- 510(k) Number
- K260462 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 RCT800 is a computed tomography, dental X-ray tomography system. It is a CBCT and panoramic X-ray imaging system with cephalometric capability, providing diagnostic support for adult and pediatric patients in maxillofacial, sinus, TMJ, airway, and carpus imaging for growth and maturity assessment in orthodontic treatment.
The RCT800 system is supplied as a dental imaging device and has received FDA 510(k) clearance (K260462) as a substantially equivalent device under product code OAS and regulation number 892.1750. It is classified as a Class II medical device in the radiology specialty and is intended for use in clinical imaging settings. The device is not described as sterile, single-use, or reusable in the provided data, and no MRI safety information is specified.
Frequently asked questions
What is the RCT800 used for?
The RCT800 is a computed tomography, dental X-ray tomography system that provides diagnostic support for adult and pediatric patients in maxillofacial, sinus, TMJ, airway, and carpus imaging for growth and maturity assessment in orthodontic treatment.
How is the RCT800 supplied and what type of device is it?
The RCT800 system is supplied as a dental imaging device and is classified as a Class II medical device in the radiology specialty, intended for use in clinical imaging settings.
Is the RCT800 sterile, single-use, or reusable?
The device is not described as sterile, single-use, or reusable in the provided data, so no information on sterility or reusability is available from the authorization details.
What regulatory pathway was used for the RCT800?
The RCT800 has received FDA 510(k) clearance (K260462) as a substantially equivalent device under product code OAS and regulation number 892.1750.
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: PDF Ray Co., Ltd. Changhwan Lee RA Manager, Ray Co., Ltd RCT800-CT,Pano (L)+OCL RAYSCAN Studio, PDF Ray Co., Ltd., Ray Co., Ltd. FDA 510 (k) Radiology Products - Latest 2026
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K260462 | Class II | Active |
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Manufacturer
- Manufacturer
- Ray Co., Ltd
- FDA Applicant
- Ray Co., Ltd.
Sources (1)
- FDA 510(k) K260462 24 fields · synced Sep 27, 2026