The following data is part of a premarket notification filed by Fujifilm Medical System U.s.a., Inc. with the FDA for Fdr Image Stitching Option.
| Device ID | K101686 |
| 510k Number | K101686 |
| Device Name: | FDR IMAGE STITCHING OPTION |
| Classification | System, X-ray, Stationary |
| Applicant | FUJIFILM MEDICAL SYSTEM U.S.A., INC. 419 WEST AVE. Stamford, CT 06902 -6300 |
| Contact | Debbie Peacock |
| Correspondent | Debbie Peacock FUJIFILM MEDICAL SYSTEM U.S.A., INC. 419 WEST AVE. Stamford, CT 06902 -6300 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-16 |
| Decision Date | 2010-10-29 |