The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Synapse 3d Base Tools V6.6.
| Device ID | K221677 |
| 510k Number | K221677 |
| Device Name: | Synapse 3D Base Tools V6.6 |
| Classification | System, Image Processing, Radiological |
| Applicant | FUJIFILM Corporation 26-30 Nishiazabu, 2-Chome Minato-Ku, JP 106-8620 |
| Contact | Randy Vader |
| Correspondent | Jeffrey Wan FUJIFILM Healthcare Americas Corporation 81 Hartwell Avenue, Suite 300 Lexington, MA 02421 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-09 |
| Decision Date | 2022-11-10 |