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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 K123408
Device Name ERGO IMAGING SYSTEM
Applicant
Digirad Corp.
13950 Stowe Dr.
Poway,  CA  92064 -8803
Applicant Contact MATTHEW OLOW
Correspondent
Digirad Corp.
13950 Stowe Dr.
Poway,  CA  92064 -8803
Correspondent Contact MATTHEW OLOW
Regulation Number892.1100
Classification Product Code
IYX  
Date Received11/05/2012
Decision Date 01/15/2013
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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