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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 K161674
Device Name QuantumCam
Applicant
Ddd-Diagnostic A/S
Dr. Neergaards Vej 5e
Horsholm,  DK 2970
Applicant Contact Niels Sorensen
Correspondent
Ddd-Diagnostic A/S
Dr. Neergaards Vej 5e
Horsholm,  DK 2970
Correspondent Contact Niels Sorensen
Regulation Number892.1200
Classification Product Code
KPS  
Date Received06/16/2016
Decision Date 10/20/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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