MODIFICATION TO AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS


Device Classification Name

system, imaging, pulsed echo, ultrasonic

510(k) Number K080930
Device Name MODIFICATION TO AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS
Applicant
U-SYSTEM, INC.
110 rose orchard way
san jose, 
CA 
95134

Applicant Contact lisa scott
Correspondent
U-SYSTEM, INC.
110 rose orchard way
san jose, 
CA 
95134

Correspodent Contact lisa scott
Regulation Number 892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received 04/02/2008
Decision Date 08/07/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No