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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Therapeutic, X-Ray
510(k) Number K162568
Device Name INTRABEAM 600
Applicant
Carl Zeiss Meditec, AG
Goeschwitzer St. 51-52
Jena,  DE 07745
Applicant Contact Christian Muenster
Correspondent
Biologics Consulting
400 N. Washington St.
Suite 100
Alexandria,  VA  22314
Correspondent Contact Calley Herzog
Regulation Number892.5900
Classification Product Code
JAD  
Date Received09/14/2016
Decision Date 12/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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