510(k) K260367
K260367 is an FDA 510(k) premarket notification submitted by PDX Co., Ltd. for the device "Portable Dental X-ray System Model PDX nova". The FDA issued a decision of Substantially Equivalent on May 27, 2026. 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
- May 27, 2026
- Date Received
- February 4, 2026
- 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