The following data is part of a premarket notification filed by Fujifilm Medical Systems U.s.a., Inc. with the FDA for Fcr Go Portable Digital X-ray System.
| Device ID | K080945 |
| 510k Number | K080945 |
| Device Name: | FCR GO PORTABLE DIGITAL X-RAY SYSTEM |
| Classification | System, X-ray, Mobile |
| Applicant | FUJIFILM MEDICAL SYSTEMS U.S.A., INC. 419 WEST AVE. Stamford, CT 06902 -6300 |
| Contact | Debbie Peacock |
| Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-04-03 |
| Decision Date | 2008-04-18 |
| Summary: | summary |