510(k) K131314
K131314 is an FDA 510(k) premarket notification submitted by Swissray Medical AG for the device "DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM)". The FDA issued a decision of Substantially Equivalent on Jun 25, 2013. The device falls under product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)), a Class II device regulated under 21 CFR 892.1680. Swissray Medical AG has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 25, 2013
- Date Received
- May 7, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Solid State X-Ray Imager (Flat Panel/Digital Imager)
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type