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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Densitometer, Bone
510(k) Number K220402
Device Name VirtuOst
Applicant
O.N. Diagnostics
2150 Shattuck Ave. Suite 610
Berkeley,  CA  94704
Applicant Contact David Kopperdahl
Correspondent
O.N. Diagnostics
1936 University Ave. Suite 280
Berkeley,  CA  94704
Correspondent Contact David Kopperdahl
Regulation Number892.1170
Classification Product Code
KGI  
Date Received02/11/2022
Decision Date 05/19/2023
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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