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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 K232088
Device Name Altris IMS
Applicant
Altris, Inc.
125 South Clark Street, 17th Floor
Chicago,  IL  60603
Applicant Contact Andrew Kuropyatnyk
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number892.2050
Classification Product Code
NFJ  
Date Received07/13/2023
Decision Date 07/31/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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