The following data is part of a premarket notification filed by Fujifilm Medical Systems U.s.a., Inc. with the FDA for Aspire Cristalle.
| Device ID | K173132 |
| 510k Number | K173132 |
| Device Name: | ASPIRE Cristalle |
| Classification | Full Field Digital, System, X-ray, Mammographic |
| 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 | MUE |
| CFR Regulation Number | 892.1715 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2017-10-27 |
| Summary: | summary |