K260367
- 510(k) number
- K260367
- Device name
- Portable Dental X-ray System Model PDX nova
- Applicant
- PDX Co., Ltd. CN
- Product code
- EHD — Unit, X-Ray, Extraoral With Timer
- Decision date
- 2026-05-27
- Date received
- 2026-02-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K260367.pdf
Official FDA record: K260367
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.