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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 K260500
Device Name ResolutionMD
Applicant
ResolutionMD, Inc.
Suite 314, 1212 31 Ave. NE
Calgary,  CA T2E 7S8
Applicant Contact Sharon Cholowsky
Correspondent
ResolutionMD, Inc.
Suite 314, 1212 31 Ave. NE
Calgary,  CA T2E 7S8
Correspondent Contact Sharon Cholowsky
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/13/2026
Decision Date 07/21/2026
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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