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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Densitometer, Bone
510(k) Number K901854
Device Name GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412)
Applicant
Amersham Corp.
2636 S. Clearbrook Dr.
Arlington Heights,  IL  60005
Applicant Contact B PATTERSON
Correspondent
Amersham Corp.
2636 S. Clearbrook Dr.
Arlington Heights,  IL  60005
Correspondent Contact B PATTERSON
Regulation Number892.1170
Classification Product Code
KGI  
Date Received04/24/1990
Decision Date 07/09/1990
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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