K251438
- 510(k) number
- K251438
- Device name
- Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )
- Applicant
- Guilin Woodpecker Medical Instrument Co., Ltd. CN
- Product code
- EHD — Unit, X-Ray, Extraoral With Timer
- Decision date
- 2025-09-04
- Date received
- 2025-05-09
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K251438.pdf
Official FDA record: K251438
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.