K252909
- 510(k) number
- K252909
- Device name
- Diagnostic X-Ray Equipment Model POCT22
- Applicant
- Ningbo Runyes Medical Instrument Co., Ltd. CN
- Product code
- EHD — Unit, X-Ray, Extraoral With Timer
- Decision date
- 2026-02-03
- Date received
- 2025-09-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K252909.pdf
Official FDA record: K252909
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.