K260462

Substantially Equivalent

RCT800

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.

Applicant: Ray Co., Ltd.
Product code: OAS
Advisory panel: Radiology
Date received: 2026-02-12
Decision date: 2026-04-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Yongin-Si, KR

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.