The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Fdr D-evo Iii Flat Panel Detector System.
| Device ID | K192932 |
| 510k Number | K192932 |
| Device Name: | FDR D-EVO III Flat Panel Detector System |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-gun, JP 258-8538 |
| Contact | Randy Vader |
| Correspondent | Kamila Sak FUJIFILM Medical Systems U.S.A, Inc. 81 Hartwell Avenue, Suite 300 Lexington, MA 02421 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-17 |
| Decision Date | 2019-11-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547410483437 | K192932 | 000 |
| 04547410426915 | K192932 | 000 |
| 04547410426922 | K192932 | 000 |
| 04547410436983 | K192932 | 000 |
| 04547410445428 | K192932 | 000 |
| 04547410445442 | K192932 | 000 |
| 04547410445466 | K192932 | 000 |
| 04547410445480 | K192932 | 000 |
| 04547410445503 | K192932 | 000 |
| 04547410478631 | K192932 | 000 |
| 04547410478648 | K192932 | 000 |
| 04547410478655 | K192932 | 000 |
| 04547410480771 | K192932 | 000 |
| 04547410480788 | K192932 | 000 |
| 04547410483420 | K192932 | 000 |
| 04547410426908 | K192932 | 000 |