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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K960622
Device Name I-SCAN
Applicant
Ophthalmic Technologies, Inc.
37 Kodiak Crescent,
Unit 12
Downsview, Ontario,  CA MEJ 3E5
Applicant Contact RISHARD WEITZ
Correspondent
Ophthalmic Technologies, Inc.
37 Kodiak Crescent,
Unit 12
Downsview, Ontario,  CA MEJ 3E5
Correspondent Contact RISHARD WEITZ
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received02/13/1996
Decision Date 05/13/1996
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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