510(k) K170731
K170731 is an FDA 510(k) premarket notification submitted by VATECH Co., Ltd. for the device "System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight". The FDA issued a decision of Substantially Equivalent on April 4, 2017. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. VATECH Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 2017
- Date Received
- March 10, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Extraoral Source, Digital
- Device Class
- Class II
- Regulation Number
- 872.1800
- Review Panel
- RA
- Submission Type