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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 K210556
Device Name Preview Shoulder
Applicant
Genesis Software Innovations
220 Lyon St NW Suite 500
grand rapids,  MI  49503
Applicant Contact matt miller
Correspondent
Genesis Software Innovations
220 Lyon St NW Suite 500
grand rapids,  MI  49503
Correspondent Contact matt miller
Regulation Number892.2050
Classification Product Code
QIH  
Date Received02/25/2021
Decision Date 04/21/2021
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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