The following data is part of a premarket notification filed by Fujifilm Medical Systems, Usa Inc. with the FDA for Aspire Hd Full-field Digital Mammography System.
| Device ID | K110729 |
| 510k Number | K110729 |
| Device Name: | ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM |
| Classification | Full Field Digital, System, X-ray, Mammographic |
| Applicant | FUJIFILM MEDICAL SYSTEMS, USA INC. 419 WEST AVENUE Stamford, CT 06902 |
| Contact | Peter Altman |
| Correspondent | Peter Altman FUJIFILM MEDICAL SYSTEMS, USA INC. 419 WEST AVENUE Stamford, CT 06902 |
| Product Code | MUE |
| CFR Regulation Number | 892.1715 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-16 |
| Decision Date | 2011-09-01 |
| Summary: | summary |