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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, fluoroscopic, image-intensified
510(k) Number K150306
Device Name D2RS_AT Digital Dynamic Remote System
Applicant
STEPHANIX RADIOLOGICAL SOLUTIONS
RUE JEAN MOULIN
ZI DU BAYOU
LA RICAMARIE,  FR 42150
Applicant Contact SANDIE PERRET
Correspondent
Kamm & Associates
8870 RAVELLO CT.
NAPLES,  FL  34114
Correspondent Contact DANIEL KAMM
Regulation Number892.1650
Classification Product Code
JAA  
Date Received02/09/2015
Decision Date 10/10/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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