The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Synapse Pacs.
| Device ID | K190232 |
| 510k Number | K190232 |
| Device Name: | Synapse PACS |
| Classification | System, Image Processing, Radiological |
| Applicant | FUJIFILM Corporation 26-30 Nishiazabu, 2-Chome Minato-ku Tokyo, JP 106-8620 |
| Contact | Randy Vader |
| Correspondent | Senita Sims FUJIFILM Medical Systems U.S.A., Inc. 81 Hartwell Ave 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 | 2019-02-06 |
| Decision Date | 2019-03-26 |