Device Listing 1934108122
Listing Summary#
- Listing key
- 1934108122
- Premarket submission
- K111646
- Device
- ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR
- Applicant
- Fujifilm Medical System U.S.A., Inc.
- Product code
- MUE
- Decision date
- 2011-12-08