HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNER


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K110673
Device Name HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNER
Applicant
HITACHI MEDICAL SYSTEMS AMERICA, INC.
1959 summit commerce park
twinsburg, 
OH 
44087

Applicant Contact doug thistlethwaite
Correspondent
HITACHI MEDICAL SYSTEMS AMERICA, INC.
1959 summit commerce park
twinsburg, 
OH 
44087

Correspodent Contact doug thistlethwaite
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received 03/09/2011
Decision Date 09/27/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No