The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Aspire Cristalle.
| Device ID | K212873 |
| 510k Number | K212873 |
| Device Name: | Aspire Cristalle |
| Classification | Full Field Digital, System, X-ray, Mammographic |
| Applicant | FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-Gun, JP 258-8538 |
| Contact | Randy Vader |
| Correspondent | Jeffrey Wan FUJIFLM Medical Systems U.S.A, Inc. 81 Hartwell Avenue, Suite 300 Lexington, MA 02421 |
| Product Code | MUE |
| CFR Regulation Number | 892.1715 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-09 |
| Decision Date | 2022-05-27 |