The following data is part of a premarket notification filed by Fujifilm Medical Systems U.s.a., Inc. with the FDA for Dynamic Visualization Ii Image Processing Option For The Fdx Console (dr-id300cl Of The Dr-id600).
| Device ID | K163624 |
| 510k Number | K163624 |
| Device Name: | Dynamic Visualization II Image Processing Option For The FDX Console (DR-ID300CL Of The DR-ID600) |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | FUJIFILM Medical Systems U.S.A., Inc. 419 West Avenue Stamford, CT 06902 |
| Contact | Dharaben Desai |
| Correspondent | Dharaben Desai FUJIFILM Medical Systems U.S.A., Inc. 419 West Avenue Stamford, CT 06902 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-22 |
| Decision Date | 2017-06-30 |
| Summary: | summary |