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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 K971685
Device Name IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM
Applicant
TOMEY CORPORATION USA
555 THIRTEENTH ST., N.W.
WASHINGTON,  DC  20004 -1109
Applicant Contact HOWARD M HOLSTEIN
Correspondent
TOMEY CORPORATION USA
555 THIRTEENTH ST., N.W.
WASHINGTON,  DC  20004 -1109
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number886.1120
Classification Product Code
HKI  
Date Received05/07/1997
Decision Date 06/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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