APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA – 790A, VERSION 2.2


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K081065
Device Name APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA – 790A, VERSION 2.2
Applicant
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 michelle dr.
p.o. box 2068
tustin, 
CA 
92781 -2068

Applicant Contact paul biggins
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received 04/15/2008
Decision Date 06/06/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No