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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 K202013
Device Name WRDensity by Whiterabbit.ai
Applicant
Whiterabbit.ai Inc.
3930 Freedom Cir. Ste 101
Santa Clara,  CA  95054
Applicant Contact Jason Su
Correspondent
Whiterabbit.ai Inc.
3930 Freedom Cir. Ste 101
Santa Clara,  CA  95054
Correspondent Contact Jason Su
Regulation Number892.2050
Classification Product Code
QIH  
Date Received07/21/2020
Decision Date 10/30/2020
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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