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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K252007
Device Name BlineSlide
Applicant
Deep Breathe, Inc.
29 Dunkirk Place
London,  CA N6C 2G5
Applicant Contact Robert Arntfield
Correspondent
Deep Breathe, Inc.
29 Dunkirk Place
London,  CA N6C 2G5
Correspondent Contact Robert Arntfield
Regulation Number892.2050
Classification Product Code
QIH  
Date Received06/27/2025
Decision Date 10/06/2025
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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