ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM


Device Classification Name

full field digital,system,x-ray,mammographic

510(k) Number K110729
Device Name ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM
Applicant
FUJIFILM MEDICAL SYSTEMS, USA INC.
419 west avenue
stamford, 
CT 
06902

Applicant Contact peter altman
Correspondent
FUJIFILM MEDICAL SYSTEMS, USA INC.
419 west avenue
stamford, 
CT 
06902

Correspodent Contact peter altman
Regulation Number 892.1715
Classification Product Code
MUE  
Date Received 03/16/2011
Decision Date 09/01/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No