K261748
- 510(k) number
- K261748
- Device name
- Dental Cone-beam Computed Tomography (mDX-15P Series)
- Applicant
- Hefei Meyer Optoelectronic Technology, Inc. CN
- Product code
- OAS — X-Ray, Tomography, Computed, Dental
- Decision date
- 2026-07-23
- Date received
- 2026-05-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K261748.pdf
Official FDA record: K261748
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.