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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tomography, Optical Coherence
510(k) Number K182942
Device Name Canon OCT-A1
Applicant
Canon Inc.
9-1, Imaikami-cho
Nakahara-ku, Kawasaki,  JP 211-08501
Applicant Contact Tatsuya Yamazaki
Correspondent
Ora, Inc.
300 Brickstone Square
Andover,  MA  01810
Correspondent Contact Ryan Bouchard
Regulation Number886.1570
Classification Product Code
OBO  
Subsequent Product Code
HLI  
Date Received10/23/2018
Decision Date 07/24/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT03716492
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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