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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K861429
Device Name DIGITRON 3V,3VA,3VAC,3 HIGH RESOLUTION UPGRADE
Applicant
Siemens Gammasonics, Inc.
2000 Nuclear Dr.
Des Plaines,  IL  60018
Applicant Contact JOSEPH P STOWELL
Correspondent
Siemens Gammasonics, Inc.
2000 Nuclear Dr.
Des Plaines,  IL  60018
Correspondent Contact JOSEPH P STOWELL
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/16/1986
Decision Date 07/25/1986
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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