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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 K210344
Device Name inVisionOS
Applicant
PrecisionOS Technology Inc.
500-319 West Hastings Street
Vancouver,  CA V6B 1H6
Applicant Contact Danny Goel
Correspondent
PrecisionOS Technology Inc.
500-319 West Hastings Street
Vancouver,  CA V6B 1H6
Correspondent Contact Danny Goel
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/05/2021
Decision Date 11/10/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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