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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Reusable Image
510(k) Number K854407
Device Name DIGIRAD REUSABLE IMAGE MEDIA
Applicant
Digirad Corp.
1047 Elwell Ct.
Palo Alto,  CA  94303
Applicant Contact CLAIRE ANDREWS-EURGL
Correspondent
Digirad Corp.
1047 Elwell Ct.
Palo Alto,  CA  94303
Correspondent Contact CLAIRE ANDREWS-EURGL
Regulation Number892.1840
Classification Product Code
LQA  
Date Received11/01/1985
Decision Date 03/10/1986
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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