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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Ophthalmic, Ac-Powered
510(k) Number K062295
Device Name IRI INTEGRATED RETINAL IMAGER
Applicant
Medivision Medical Imaging, Ltd.
20 Hata'As St.
Kfar Saba,  IL 44425
Applicant Contact AHAVA STEIN
Correspondent
Medivision Medical Imaging, Ltd.
20 Hata'As St.
Kfar Saba,  IL 44425
Correspondent Contact AHAVA STEIN
Regulation Number886.1120
Classification Product Code
HKI  
Date Received08/07/2006
Decision Date 10/20/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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