The following data is part of a premarket notification filed by Fujifilm Medical Systems Usa, Inc. with the FDA for Fuji Synapse Workstation Software.
| Device ID | K051553 |
| 510k Number | K051553 |
| Device Name: | FUJI SYNAPSE WORKSTATION SOFTWARE |
| Classification | System, Image Processing, Radiological |
| Applicant | FUJIFILM MEDICAL SYSTEMS USA, INC. 419 WEST AVENUE Stamford, CT 06902 |
| Contact | Robert Berry |
| Correspondent | Jeffrey D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-06-13 |
| Decision Date | 2005-07-07 |
| Summary: | summary |