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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 K210726
Device Name ImmersiveTouch
Applicant
ImmersiveTouch, Inc.
910 W Van Buren St, Suite 715
Chicago,  IL  60607
Applicant Contact P. Pat Banerjee
Correspondent
ImmersiveTouch, Inc.
910 W Van Buren St, Suite 715
Chicago,  IL  60607
Correspondent Contact P. Pat Banerjee
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/11/2021
Decision Date 09/29/2021
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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