The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Synapse 3d Optional Tools.
| Device ID | K181773 |
| 510k Number | K181773 |
| Device Name: | Synapse 3D Optional Tools |
| Classification | System, Image Processing, Radiological |
| Applicant | FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-gun, JP 258-8538 |
| Contact | Randy Vader |
| Correspondent | Jeffrey Wan FUJIFILM Medical Systems U.S.A., Inc. 419 West Avenue Stamford, CT 06902 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-03 |
| Decision Date | 2018-09-25 |
| Summary: | summary |