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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 K172058
Device Name CT6485, CT12885
Applicant
Analogic Corporation
8 Centennial Dr.
Peabody,  MA  01960
Applicant Contact Karen Provencher
Correspondent
Analogic Corporation
8 Centennial Dr.
Peabody,  MA  01960
Correspondent Contact Karen Provencher
Regulation Number892.1750
Classification Product Code
JAK  
Date Received07/06/2017
Decision Date 02/13/2018
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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