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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
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