The following data is part of a premarket notification filed by Fujifilm Medical System U.s.a., Inc. with the FDA for Wireless/wired Fdr D-evo Flat Pancel Detector System Model Dr-id600 W/dr-id611se.
| Device ID | K111548 |
| 510k Number | K111548 |
| Device Name: | WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE |
| 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 | Katherine Y Choi |
| Correspondent | Katherine Y Choi 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 | 2011-06-03 |
| Decision Date | 2011-08-30 |
| Summary: | summary |