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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Image Processing Software For Radiation Therapy
510(k) Number K241837
Device Name Limbus Contour
Applicant
Limbus AI Inc.
2431 Glamis Place
Regina,  CA S4N3K9
Applicant Contact Jonathan Giambattista
Correspondent
Limbus AI Inc.
2431 Glamis Place
Regina,  CA S4N3K9
Correspondent Contact Jonathan Giambattista
Regulation Number892.2050
Classification Product Code
QKB  
Date Received06/25/2024
Decision Date 10/09/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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