The following data is part of a premarket notification filed by Fujifilm Medical System U.s.a., Inc. with the FDA for Aspire Hd Plus, Aspire Hd-s.
| Device ID | K121674 |
| 510k Number | K121674 |
| Device Name: | ASPIRE HD PLUS, ASPIRE HD-S |
| Classification | Full Field Digital, System, X-ray, Mammographic |
| Applicant | FUJIFILM MEDICAL SYSTEM U.S.A., INC. 419 WEST AVE. Stamford, CT 06902 -6300 |
| Contact | Peter Altman |
| Correspondent | Peter Altman FUJIFILM MEDICAL SYSTEM U.S.A., INC. 419 WEST AVE. Stamford, CT 06902 -6300 |
| Product Code | MUE |
| CFR Regulation Number | 892.1715 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-06 |
| Decision Date | 2012-09-21 |
| Summary: | summary |