510(k) K223780
K223780 is an FDA 510(k) premarket notification submitted by 3Dio for the device "Lumos 3DX". The FDA issued a decision of Substantially Equivalent on July 6, 2023. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 6, 2023
- Date Received
- December 16, 2022
- Clearance Type
- Traditional
- 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