APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM


Device Classification Name

transducer, ultrasonic, diagnostic

510(k) Number K103645
Device Name APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN
2441 michelle dr
tustin, 
CA 
92780

Applicant Contact paul biggins
Correspondent
TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN
2441 michelle dr
tustin, 
CA 
92780

Correspodent Contact paul biggins
Regulation Number 892.1570
Classification Product Code
ITX  
Subsequent Product Codes
DQK   IYN   IYO  
Date Received 12/13/2010
Decision Date 01/12/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Special
Reviewed by Third Party No

Combination Product

No