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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Management, Ophthalmic
510(k) Number K110869
FOIA Releasable 510(k) K110869
Device Name CARA
Applicant
Diagnos, Inc.
300 Brickstone Sq.
Andover,  MA  01810
Applicant Contact Aron Shapiro
Correspondent
Diagnos, Inc.
300 Brickstone Sq.
Andover,  MA  01810
Correspondent Contact Aron Shapiro
Regulation Number892.2050
Classification Product Code
NFJ  
Date Received03/29/2011
Decision Date 07/14/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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