510(k) K163624
Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) by
Fujifilm Medical Systems U.S.A, Inc.
— Product Code MQB
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 30, 2017
- Date Received
- December 22, 2016
- Clearance Type
- Traditional
- 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