K260462
- 510(k) number
- K260462
- Device name
- RCT800
- Applicant
- Ray Co., Ltd. KR
- Product code
- OAS — X-Ray, Tomography, Computed, Dental
- Decision date
- 2026-04-09
- Date received
- 2026-02-12
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K260462.pdf
Official FDA record: K260462
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.