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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 K140860
Device Name ImmersiveTouch3 and MicrovisTouch
Applicant
IMMERSIVE TOUCH
708 KRISTIN COURT
WESTMONT,  IL  60559
Applicant Contact PRASHANT BANERJEE
Correspondent
IMMERSIVE TOUCH
708 KRISTIN COURT
WESTMONT,  IL  60559
Correspondent Contact PRASHANT BANERJEE
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/03/2014
Decision Date 12/16/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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