The following data is part of a premarket notification filed by Fujifilm Meidcal Systems U.s.a..,inc. with the FDA for Synapse 3d Tensor Analysis.
| Device ID | K141514 |
| 510k Number | K141514 |
| Device Name: | SYNAPSE 3D TENSOR ANALYSIS |
| Classification | System, Image Processing, Radiological |
| Applicant | FUJIFILM MEIDCAL SYSTEMS U.S.A..,INC. 149 WEST AVENUE Stamford, CT 06902 |
| Contact | Jyh-shyan Lin |
| Correspondent | Jyh-shyan Lin FUJIFILM MEIDCAL SYSTEMS U.S.A..,INC. 149 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 | 2014-06-09 |
| Decision Date | 2014-09-03 |
| Summary: | summary |