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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K162314
Device Name IMACTIS CT-Navigation system
Applicant
Imactis, Sas
5 Ave. Du Grand Sablon
La Tronche,  FR 38700
Applicant Contact MADY BATAILH
Correspondent
Imactis, Sas
5 Ave. Du Grand Sablon
La Tronche,  FR 38700
Correspondent Contact MADY BATAILH
Regulation Number892.1750
Classification Product Code
JAK  
Date Received08/18/2016
Decision Date 04/24/2018
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
Recalls CDRH Recalls
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