The following data is part of a premarket notification filed by Fujifilm Medical Systems Usa, Inc. with the FDA for Synapse Mip/mpr Image Visualization Software Obliquus.
| Device ID | K061672 |
| 510k Number | K061672 |
| Device Name: | SYNAPSE MIP/MPR IMAGE VISUALIZATION SOFTWARE OBLIQUUS |
| Classification | System, Image Processing, Radiological |
| Applicant | FUJIFILM MEDICAL SYSTEMS USA, INC. 419 WEST AVENUE Stamford, CT 06902 |
| Contact | Debbie Peacock |
| Correspondent | Casey Conry UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-06-14 |
| Decision Date | 2006-06-29 |
| Summary: | summary |