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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 K230045
Device Name HipCheck
Applicant
Stryker Corp.
5900 Optical Ct
San Jose,  CA  95138
Applicant Contact Lucas Dan
Correspondent
Stryker Corp.
5900 Optical Ct
San Jose,  CA  95138
Correspondent Contact Lucas Dan
Regulation Number892.2050
Classification Product Code
QIH  
Date Received01/06/2023
Decision Date 09/29/2023
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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