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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K163394
Device Name Hybrid3D
Applicant
Hermes Medical Solutions AB
Skeppsbron 44
Stockholm,  SE 11130
Applicant Contact Joakim Arwidson
Correspondent
Hermes Medical Solutions AB
Skeppsbron 44
Stockholm,  SE 11130
Correspondent Contact Joakim Arwidson
Regulation Number892.1200
Classification Product Code
KPS  
Date Received12/05/2016
Decision Date 05/22/2017
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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