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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 K153284
Device Name Synaptive ImageDrive Pro
Applicant
SYNAPTIVE MEDICAL INC.
MARS CENTER, SOUTH TOWER, 101 COLLEGE STREET, SUITE 200
TORONTO,  CA M5G1L7
Applicant Contact Cameron Piron
Correspondent
SYNAPTIVE MEDICAL INC.
MARS CENTER, SOUTH TOWER, 101 COLLEGE STREET, SUITE 200
TORONTO,  CA M5G1L7
Correspondent Contact Cameron Piron
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/12/2015
Decision Date 03/29/2016
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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