The following data is part of a premarket notification filed by Fujifilm Medical System U.s.a., Inc. with the FDA for Wired/ Wireless Fdr D-evo With X-ray Detection Feature.
| Device ID | K111865 |
| 510k Number | K111865 |
| Device Name: | WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | FUJIFILM MEDICAL SYSTEM U.S.A., INC. 419 WEST AVE. Stamford, CT 06902 -6300 |
| Contact | Debbie Peacock |
| Correspondent | Debbie Peacock FUJIFILM MEDICAL SYSTEM U.S.A., INC. 419 WEST AVE. Stamford, CT 06902 -6300 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-30 |
| Decision Date | 2011-09-30 |
| Summary: | summary |