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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 K230249
Device Name Ikshana
Applicant
ImmersiveTouch
910 W Van Buren Street
Suite 715
Chicago,  IL  60607
Applicant Contact Prashant Banerjee
Correspondent
ImmersiveTouch
910 W Van Buren Street
Suite 715
Chicago,  IL  60607
Correspondent Contact Prashant Banerjee
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/30/2023
Decision Date 10/16/2023
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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