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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Scintillation (Gamma)
510(k) Number K961104
Device Name NOTEBOOK IMAGER
Applicant
Digirad Corp.
14900 Sweitzer Ln.
Suite 200
Laurel,  MD  20707
Applicant Contact JAMES M HOWARD
Correspondent
Digirad Corp.
14900 Sweitzer Ln.
Suite 200
Laurel,  MD  20707
Correspondent Contact JAMES M HOWARD
Regulation Number892.1100
Classification Product Code
IYX  
Date Received03/20/1996
Decision Date 05/28/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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