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ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K111646
510(k) Type
Traditional
Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/8/2011
Days to Decision
178 days
Submission Type
Summary

ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K111646
510(k) Type
Traditional
Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/8/2011
Days to Decision
178 days
Submission Type
Summary