K231055
- 510(k) number
- K231055
- Device name
- x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)
- Applicant
- De Götzen S.R.L. IT
- Product code
- EHD — Unit, X-Ray, Extraoral With Timer
- Decision date
- 2023-12-28
- Date received
- 2023-04-13
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K231055.pdf
Official FDA record: K231055
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.