SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS)


Device Classification Name

transducer, ultrasonic, diagnostic

510(k) Number K080555
Device Name SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS)
Applicant
IVU IMAGING CORPORATION
4121 grace lane
grapevine, 
TX 
76051

Applicant Contact mark l stribling
Regulation Number 892.1570
Classification Product Code
ITX  
Subsequent Product Code
IYO  
Date Received 02/28/2008
Decision Date 06/03/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No