The following data is part of a premarket notification filed by Fujifilm Medical System U.s.a., Inc. with the FDA for Synapse Obliquus Mip/mpr/fusion.
| Device ID | K100881 |
| 510k Number | K100881 |
| Device Name: | SYNAPSE OBLIQUUS MIP/MPR/FUSION |
| Classification | System, Image Processing, Radiological |
| Applicant | FUJIFILM MEDICAL SYSTEM U.S.A., INC. 419 WEST AVE. Stamford, CT 06902 -6300 |
| Contact | Peter Altman |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-03-30 |
| Decision Date | 2010-04-14 |
| Summary: | summary |