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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
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