XARIO 200 DIAGNOSTIC ULTRASOUND SYSTEM

Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K131507
Device Name XARIO 200 DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
TOSHIBA MEDICAL SYSTEMS CORPORATION
2441 michelle drive
tustin, 
CA 
92780

Applicant Contact charlemagne chua
Correspondent
TOSHIBA MEDICAL SYSTEMS CORPORATION
2441 michelle drive
tustin, 
CA 
92780

Correspodent Contact charlemagne chua
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received 05/24/2013
Decision Date 08/28/2013
Decision

substantially equivalent

(SESE)
Regulation Medical Specialty

Radiology

510k Review Panel

Radiology
summary

summary

Type Traditional
Reviewed by Third Party No
Combination Product

No