510(k) K183422
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 9, 2019
- Date Received
- December 10, 2018
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
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