510(k) K123493
K123493 is an FDA 510(k) premarket notification submitted by VATECH Co., Ltd. for the device "VEX-S 100W INTRAORAL X-RAY SYSTEM". The FDA issued a decision of Substantially Equivalent on Dec 13, 2012. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. VATECH Co., Ltd. has 39 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 13, 2012
- Date Received
- Nov 9, 2012
- 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
- 510(k)