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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, imaging, pulsed doppler, ultrasonic
510(K) Number K122341
Device Name PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37
Applicant
HITACHI ALOKA MEDICAL, LTD.
10 fairfield blvd.
wallingford ct,  CT  06492 7502
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received08/02/2012
Decision Date 09/26/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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