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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 K150415
Device Name NilRead
Applicant
Perceptive Software
120 Carlton St., Suite 217
toronto,  CA m5a 4k2
Applicant Contact claudio gatti
Correspondent
Perceptive Software
120 Carlton St., Suite 217
toronto,  CA m5a 4k2
Correspondent Contact sandra stapleton
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/18/2015
Decision Date 06/12/2015
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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