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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 K241049
Device Name CANON Fundus Camera CR-10 (CR-10)
Applicant
Canon, Inc.
9-1, Imaikami-Cho, Nakahara-Ku
Kawasaki,  JP 2118501
Applicant Contact Shigeo Watanabe
Correspondent
Ora, Inc.
138 Haverhill St., Suite 102
Andover,  MA  01810
Correspondent Contact Roger Albright
Regulation Number886.1120
Classification Product Code
HKI  
Date Received04/17/2024
Decision Date 05/15/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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