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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 K140206
Device Name SCINTILLATION GAMMA CAMERA
Applicant
Ddd-Diagnostic A/S
2970 Horsholm
Denmark,  DK DENMARK
Applicant Contact NEERGAARDS VEJ 5E
Correspondent
Bsi Healthcare
Kitemark Court, Davy Ave.
Knowlhill
Milton Keynes,  GB MK5 8PP
Regulation Number892.1200
Classification Product Code
KPS  
Date Received01/27/2014
Decision Date 05/08/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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