APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM


Device Classification Name

transducer, ultrasonic, diagnostic

510(k) Number K072826
Device Name APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 michelle dr.
p.o. box 2068
tustin, 
CA 
92781 -2068

Applicant Contact paul biggins
Regulation Number 892.1570
Classification Product Code
ITX  
Subsequent Product Codes
IYN   IYO  
Date Received 10/03/2007
Decision Date 10/24/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No