ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM


Device Classification Name

transducer, ultrasonic, diagnostic

510(k) Number K072285
Device Name ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM
Applicant
ALOKA CO., LTD.
10 fairfield blvd.
wallingford, 
CT 
06492

Applicant Contact richard j cehovsky
Regulation Number 892.1570
Classification Product Code
ITX  
Subsequent Product Codes
IYN   IYO  
Date Received 08/16/2007
Decision Date 08/30/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No