510(k) K251438
K251438 is an FDA 510(k) premarket notification submitted by Guilin Woodpecker Medical Instrument Co., Ltd. for the device "Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )". The FDA issued a decision of Substantially Equivalent on September 4, 2025. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Guilin Woodpecker Medical Instrument Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 4, 2025
- Date Received
- May 9, 2025
- Clearance Type
- Special
- 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