510(k) K102680
K102680 is an FDA 510(k) premarket notification submitted by Control-X Medical, Inc. for the device "Z-MOTION DIGITAL DIAGNOSTIC X-RAY SYSTEM". The FDA issued a decision of Substantially Equivalent on Oct 22, 2010. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 22, 2010
- Date Received
- Sep 17, 2010
- 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)