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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 K852284
Device Name DIGIRAD SYSTEM 1 AND THE REUSUABLE IMAGE MEDIA
Applicant
Digirad Corp.
1047 Elwell Ct.
Palo Alto,  CA  94303
Applicant Contact RAMESH C TRIVEDI
Correspondent
Digirad Corp.
1047 Elwell Ct.
Palo Alto,  CA  94303
Correspondent Contact RAMESH C TRIVEDI
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/29/1985
Decision Date 11/14/1985
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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