510(k) K231055
K231055 is an FDA 510(k) premarket notification submitted by De Götzen S.R.L. for the device "x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)". The FDA issued a decision of Substantially Equivalent on December 28, 2023. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. De Götzen S.R.L. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 28, 2023
- Date Received
- April 13, 2023
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, X-Ray, Extraoral With Timer
- Device Class
- Class II
- Regulation Number
- 872.1800
- Review Panel
- RA
- Submission Type