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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K850834
Device Name SDL-32 ELECTRONIC LINEAR SCANNER
Applicant
Shimadzu Corp.
16921 S Western Ave. #102
Gardena,  CA  90247
Applicant Contact TAKAO SOMEYAMA
Correspondent
Shimadzu Corp.
16921 S Western Ave. #102
Gardena,  CA  90247
Correspondent Contact TAKAO SOMEYAMA
Regulation Number892.1560
Classification Product Code
IYO  
Date Received03/01/1985
Decision Date 10/31/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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