510(k) K163624
K163624 is an FDA 510(k) premarket notification submitted by Fujifilm Medical Systems U.S.A, Inc. for the device "Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)". The FDA issued a decision of Substantially Equivalent on June 30, 2017. 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. Fujifilm Medical Systems U.S.A, Inc. has at least 10 other 510(k) clearances on record.
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