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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 K220733
Device Name OptiVu ROSA MxR
Applicant
Orthosoft, Inc. (d/b/a Zimmer CAS)
75 Queen St., Suite 3300
Montreal,  CA H3C 2N6
Applicant Contact Paul Hardy
Correspondent
Orthosoft, Inc. (d/b/a Zimmer CAS)
75 Queen St., Suite 3300
Montreal,  CA H3C 2N6
Correspondent Contact Paul Hardy
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
OLO  
Date Received03/14/2022
Decision Date 07/29/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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