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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, High-Voltage, X-Ray, Diagnostic
510(k) Number K903942
Device Name SHIMADZU X-RAY HIGH VOLTAGE GENERATPR AHD150G
Applicant
Shimadzu Medical Systems
101 W. Walnut St.
Gardena,  CA  90248
Applicant Contact DE MINT
Correspondent
Shimadzu Medical Systems
101 W. Walnut St.
Gardena,  CA  90248
Correspondent Contact DE MINT
Regulation Number892.1700
Classification Product Code
IZO  
Date Received08/27/1990
Decision Date 10/03/1990
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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