The following data is part of a premarket notification filed by Fujifilm Medical Systems Usa, Inc. with the FDA for Fujifilm Unity Speedsuite, Model Cr-ir 371.
| Device ID | K073650 |
| 510k Number | K073650 |
| Device Name: | FUJIFILM UNITY SPEEDSUITE, MODEL CR-IR 371 |
| Classification | System, X-ray, Stationary |
| Applicant | FUJIFILM MEDICAL SYSTEMS USA, INC. P.O. BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm FUJIFILM MEDICAL SYSTEMS USA, INC. P.O. BOX 7007 Deerfield, IL 60015 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-26 |
| Decision Date | 2008-02-06 |
| Summary: | summary |