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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 K153166
Device Name Fusion Bx
Applicant
Focal Healtcare, Inc.
10 Morrow Ave., Unit 101
Toronto,  CA M6R 2J1
Applicant Contact MAHAM ANSARI
Correspondent
Tuv Sud America, Inc.
1775 Old Hwy. 8 NW
New Brighton,  MN  55112
Correspondent Contact GEORG M BAUER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/02/2015
Decision Date 01/25/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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