The following data is part of a premarket notification filed by Fujifilm Medical Systems Usa, Inc. with the FDA for Fdr D-evo Flat Panel Detector System.
| Device ID | K132509 |
| 510k Number | K132509 |
| Device Name: | FDR D-EVO FLAT PANEL DETECTOR SYSTEM |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | FUJIFILM MEDICAL SYSTEMS USA, INC. 419 WEST AVENUE Stamford, CT 06902 |
| Contact | Katherine Y Choi |
| Correspondent | Katherine Y Choi FUJIFILM MEDICAL SYSTEMS USA, 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 | 2013-08-12 |
| Decision Date | 2013-11-25 |
| Summary: | summary |