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


Device Classification Name

full field digital,system,x-ray,mammographic

510(k) Number K111646
Device Name 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.
419 west ave.
stamford, 
CT 
06902 -6300

Applicant Contact debbie peacock
Correspondent
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
419 west ave.
stamford, 
CT 
06902 -6300

Correspodent Contact debbie peacock
Regulation Number 892.1715
Classification Product Code
MUE  
Date Received 06/13/2011
Decision Date 12/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No