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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 Processing, Radiological
510(k) Number K230575
Device Name Limbus Contour
Applicant
Limbus Ai, Inc.
2375 College Ave.
Regina,  CA S4P0S8
Applicant Contact Jon Giambattista
Correspondent
Medical Device Academy
345
Lincoln Hill Rd.
Shrewsbury,  VT  05738
Correspondent Contact Mary Vater
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/01/2023
Decision Date 04/07/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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