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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
510(k) Number K261679
Device Name BlineSlide
Applicant
Deep Breathe, Inc.
45 King St.
Suite 300
London,  CA N6A1B8
Applicant Contact Robert Arntfield
Correspondent
Deep Breathe, Inc.
45 King St. #300
London,  CA N6A1B8
Correspondent Contact Robert Arntfield
Regulation Number892.2060
Classification Product Code
POK  
Date Received05/21/2026
Decision Date 10/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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