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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 K102231
Device Name DISCOVERY NM 750B
Applicant
Ge Medical Systems Israel, Functional Imaging
4 Hayozma St.
Tirat Hacarmel,  IL 30200
Applicant Contact ELI WERNER
Correspondent
Ge Medical Systems Israel, Functional Imaging
4 Hayozma St.
Tirat Hacarmel,  IL 30200
Correspondent Contact ELI WERNER
Regulation Number892.1100
Classification Product Code
IYX  
Date Received08/09/2010
Decision Date 11/03/2010
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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