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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Applicator, Radionuclide, Remote-Controlled
510(k) Number K922554
Device Name STANDARD IMAGING HDR 1000 ION CHAMBER
Applicant
Standard Imaging, Inc.
6213 Middleton Springs Dr.,
Suite 205, P.O. Box 352
Middleton,  WI  53562
Applicant Contact RAYMOND T RIDDLE
Correspondent
Standard Imaging, Inc.
6213 Middleton Springs Dr.,
Suite 205, P.O. Box 352
Middleton,  WI  53562
Correspondent Contact RAYMOND T RIDDLE
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received05/29/1992
Decision Date 08/24/1992
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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