The following data is part of a premarket notification filed by Fujifilm Medical Systems U.s.a., Inc. with the FDA for Flat Panel Detector, Model Fdr D-evo.
| Device ID | K100762 |
| 510k Number | K100762 |
| Device Name: | FLAT PANEL DETECTOR, MODEL FDR D-EVO |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | FUJIFILM MEDICAL SYSTEMS U.S.A., INC. 419 WEST AVE. Stamford, CT 06902 |
| Contact | Debbie Peacock |
| Correspondent | Debbie Peacock FUJIFILM MEDICAL SYSTEMS U.S.A., INC. 419 WEST AVE. 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 | 2010-03-17 |
| Decision Date | 2010-07-15 |
| Summary: | summary |