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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 K844783
Device Name DPS-3300 MICRO NUCLEAR MEDICINE IMAGING COMPUTER
Applicant
Adac Laboratories
255 San Geronimo Way
Sunnvale,  CA  94086
Applicant Contact REBECCA ANDERSEN
Correspondent
Adac Laboratories
255 San Geronimo Way
Sunnvale,  CA  94086
Correspondent Contact REBECCA ANDERSEN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/10/1984
Decision Date 02/01/1985
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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