510(k) K092830
K092830 is an FDA 510(k) premarket notification submitted by VATECH Co., Ltd. for the device "DIGITAL X-RAY IMAGING SYSTEM, MODEL DRC-1000". The FDA issued a decision of Substantially Equivalent on Jul 21, 2010. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. VATECH Co., Ltd. has 39 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 21, 2010
- Date Received
- Sep 14, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, X-Ray, Stationary
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type
- 510(k)