The following data is part of a premarket notification filed by Fujifilm Medical System U.s.a., Inc. with the FDA for Aspire Cr For Mammography System (crm); Fcr Aspire Crn (reader). Note For General Radiography, Reader Is Carbon Xl2/fcr.
| Device ID | K111646 |
| 510k Number | K111646 |
| Device Name: | ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR |
| Classification | Full Field Digital, System, X-ray, Mammographic |
| Applicant | FUJIFILM MEDICAL SYSTEM U.S.A., INC. 419 WEST AVE. Stamford, CT 06902 -6300 |
| Contact | Debbie Peacock |
| Correspondent | Debbie Peacock 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 | 2011-06-13 |
| Decision Date | 2011-12-08 |
| Summary: | summary |