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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 K180394
Device Name BrightMatter Plan 1.6.0
Applicant
Synaptive Medical, Inc.
555 Richmond St. W., Suite 800
Toronto,  CA M5V 3B1
Applicant Contact Maham Ansari
Correspondent
Synaptive Medical, Inc.
555 Richmond St. W., Suite 800
Toronto,  CA M5V 3B1
Correspondent Contact Maham Ansari
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/13/2018
Decision Date 03/09/2018
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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