The following data is part of a premarket notification filed by Fujifilm Medical Systems U.s.a., Inc. with the FDA for Synapse Pacs.
| Device ID | K160108 |
| 510k Number | K160108 |
| Device Name: | Synapse PACS |
| Classification | System, Image Processing, Radiological |
| Applicant | FUJIFILM MEDICAL SYSTEMS U.S.A., INC. 419 WEST AVENUE Stamford, CT 06902 |
| Contact | Jyh-shyan Lin |
| Correspondent | Jyh-shyan Lin 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 | 2016-01-19 |
| Decision Date | 2016-02-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854904006008 | K160108 | 000 |