RCT800— 510(k) K260462
Substantially EquivalentRay Co., Ltd.
FDA 510(k) clearance K260462 for RCT800, Substantially Equivalent on 2026-04-09. Applicant: Ray Co., Ltd.. Device class: 2.
Summary
The RCT800 is filed under OAS, dental computed tomography X-ray systems. The code covers systems that produce cross-sectional diagnostic X-ray images of the intra-oral tissue and teeth.
Class II, 21 CFR 892.1750. The Radiology panel reviewed it as a Special 510(k).
Ray Co. filed from Yongin, South Korea. Review took 56 days (February 12 to April 9, 2026).
Clearance details
- Applicant
- Ray Co., Ltd.
- Product code
- Product code OAS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Yongin-Si, KR
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