The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Fdr Se Lite.
| Device ID | K192440 |
| 510k Number | K192440 |
| Device Name: | FDR SE Lite |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | Fujifilm Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-gun Kanagawa, 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2019-09-06 |
| Decision Date | 2019-11-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547410414530 | K192440 | 000 |