The following data is part of a premarket notification filed by Fujifilm Medical System U.s.a., Inc. with the FDA for Fdr D-evo Gl Flat Panel Detector System.
| Device ID | K152138 |
| 510k Number | K152138 |
| Device Name: | FDR D-EVO GL Flat Panel Detector System |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | FUJIFILM MEDICAL SYSTEM U.S.A., INC. 419 WEST AVENUE Stamford, CT 06902 |
| Contact | Katherine Y Choi |
| Correspondent | Katherine Y Choi FUJIFILM MEDICAL SYSTEM 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 | 2015-07-31 |
| Decision Date | 2015-11-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547410322934 | K152138 | 000 |
| 04547410322927 | K152138 | 000 |