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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K110202
Device Name FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB
Applicant
Fujifilm Medical System U.S.A., Inc.
419 W. Ave.
Stamford,  CT  06902
Applicant Contact KATHERINE Y CHOI
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number892.1570
Classification Product Code
ITX  
Subsequent Product Codes
IYN   IYO  
Date Received01/24/2011
Decision Date 02/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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