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..
Summary
The RCT800 is a dental cone-beam computed tomography (CBCT) imaging system — product code OAS covers dental CBCT and panoramic X-ray systems used for implant planning, endodontic diagnosis, and orthodontic workup. Ray Co. is one of several Korean dental-imaging manufacturers active in the US market.
Radiology panel, Special 510(k) — a modification to a previously cleared Ray Co. CBCT system rather than a new platform. Special pathway generally clears hardware iterations and software-version updates on otherwise-unchanged cleared devices.
Ray Co., Ltd. files from Yongin-Si, Korea. Roughly two-month review clock, appropriate for Special 510(k) in this category.
Clearance details
- Applicant
- Ray Co., Ltd.
- Product code
- Code OAS
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Yongin-Si, KR
Data sourced from openFDA. This site is unofficial and independent of the FDA.