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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 K240172
Device Name Preview Shoulder
Applicant
Genesis Software Innovations
2851 Charlevoix Dr. SE
Suite 327
Grand Rapids,  MI  49546
Applicant Contact Matt Miller
Correspondent
Genesis Software Innovations
2851 Charlevoix Dr. SE
Suite 327
Grand Rapids,  MI  49546
Correspondent Contact Matt Miller
Regulation Number892.2050
Classification Product Code
QIH  
Date Received01/22/2024
Decision Date 04/04/2024
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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